Careers at Outcome

At Outcome, we consider our employees a key asset and a competitive advantage. We are always interested in qualified professionals in all areas of our rapidly growing company, including scientific affairs, program and research design, web development, data management, project management, user recruitment, training, support, and analytic services. We are an equal opportunity employer and offer competitive salaries and benefits. Outcome is one of the fastest growing companies in the healthcare technology and services industry. If you are interested in being part of a dynamic, emerging company, let us know.

Positions currently available: 

Professional Services

Director of Clinical Operations

We are looking for a Director of Clinical Operations. This position will have ultimate responsibility for the oversight of the Project Management and Clinical Site Management teams. This includes: Management of resources, execution of work and overall profitability of Sponsor projects; Serve as expert internal and external resource for all projects across a variety of disease areas; Define, document, implement and update methodology for launching and operating Outcome programs. Candidates must have Degree in science, public health - an advanced degree in related field or an MBA is a plus; Minimum of 12 years in applied clinical research, with some experience with observational safety studies and at least 5 of those years at the management level; Must have excellent communication and interpersonal skills, be highly organized and self motivated with a proven ability to determine and meet objectives; the ability to collaborate with other managers to ensure appropriate direction and supervision of shared resources is critical.

Project Manager/Senior Project Manager

With direct supervision from the Program Manager or a Senior Project Manager, the Project Manager is responsible for all aspects of project administration and data coordination for multiple large-scale, Internet-based outcome studies.  Based on experience and advances project management skills, PM's will be placed on projects that are of significant revenue importance and/or have a high degree of complexity (i.e., breadth and/or depth of scope in client requirements).  This positon requires a Bachelor's degree (Master's degree preferred) and 2 or more years of Clinical Project Management experience in the healthcare, medical research, or healthcare technology setting.  Candidates must have excellent communication and organizational skills and have proven ability to manage large-scale projects. 

Senior Clinical Data Manager

The Senior Clinical Data Manager will assist with meeting all of Outcome’s data management needs including managing database development and data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines. This person will also manage and mentor Clinical Data Managers, Programmers and Medical Coders. This position requires a Bachelors degree, Masters preferred along with a minimum of 6 years experience in clinical data management with at least 2 of those years leading and managing data management projects and mentoring Clinical Data Managers. Candidates must have direct experience with FDA regulations for healthcare along with experience in GCP, regulatory and ICH guidelines applicable to Clinical Data Management. The ideal candidate would have experience with EDC and the entire Data Management lifecycle, data management systems, MS Office Applications, coding dictionaries and knowledge with medical terminology. Must have the ability to work independently and with a team and have excellent organizational, communication and interpersonal skills.

Clinical Data Manager

As a member of the Data Management team you will be managing database development and data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines. Among other responsibilities you will review clinical trial and patient registry data according to client needs, protocol endpoints from a risk management approach and develop CRFs and eCRFs for completeness, content, standards, and database considerations. This position requires a Bachelor’s degree; two or more years of experience working within the healthcare/technology industry and experience working with EDC and databases. The ideal person will also have the ability to learn quickly, multi-task and prioritize; superior computer, organizational, communication (both written and verbal) and client service skills.

Data Management Programmer

As a Data Management Programmer you will develop specifications and perform testing to assure solid database development. You will assist in the development of customized queries and reports to allow efficient data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines and support Clinical Data Managers to ensure consistent and appropriate management of clinical data. You will independently manage portions of a project once in production which includes tracking progress on deliverables and production; execute validation and Users Acceptance Testing plans and understand how EDC technology can impact data entry; and identify gaps in protocol details that are necessary for successful CRF Design, database design, data cleaning and evaluation of study results and safety data reporting. You will design clinical data base structure for data acquisition, data entry and validation; implement clinical database structure for data validation, extraction, analysis and reporting and apply standard data validations techniques, software and guidelines to routine data cleaning activities. This position requires a Bachelor’s Degree and a minimum of 5 years experience in clinical data management or registries. Proficiency with data management systems and knowledge of database design and database concepts and experience with three or more programming languages i.e. Java, J2E, SAS Access, VBA is required. Also required is experience with CRF development, data review and query development. Must have the ability to communicate concepts, identify solutions to appropriate staff and ability to work independently and in a team setting. Excellent organizational, communication and interpersonal skills are required as well as attention to detail, ability to prioritize and handle multiple project.

Technical Project Manager

The Technical Project Manager will define technical requirements, create/approve project specifications, manage project team resources in all departments and communicate directly with clients to facilitate successful project delivery. This person will improve the quality and coverage of technical documentation and work with management to identify and prioritize documentation needs. This individual may manage and mentor a team. The requirements for this role are; Bachelors degree, Engineering or Computer Science preferred, 4+ years of software or technical writing experience and must have superior written and verbal communication skills. The ideal candidate must have successful client facing experience, be a self-starter and have the ability to take initiative and be decisive.

Clinical Research Associate I

As a Clinical Research Associate (CRA I) I you will provide support to all project participants in use of the company’s internet-based data management tools and in all aspects of Site Management including site recruitment, site qualification, site enrollment (including IRB/EC support and regulatory document collection), training, ongoing support, and monitoring of customer satisfaction. You will perform comprehensive, articulate trainings and resolving customer support issues are two key components of the position. You will also participate in study development and start-up process including the creation and review of clinical and project-related documents, conduct initial and ongoing site, sponsor, and project staff training as necessary and serve as primary contact for all site interactions and as liaison between users and Project Managers. This position requires a Bachelors degree, preferably in health or life science and 6 months – 1 year of experience in a clinical research setting. You must be able to handle multiple tasks and work on multiple project teams simultaneously and have the ability to take initiative and work independently. Excellent verbal/written communication, presentation skills, time management, decision making, customer service, and interpersonal skills are required. Strong computer skills including experience with Microsoft Word, Excel, Powerpoint and Outlook and experience with Electronic Data Capture (EDC) is preferred.

Technical Support Representative

As a Technical Support Representative you will provide technical support to all project participants in use of the company’s internet-based data management tools and in all aspects of Site Management including training, ongoing support, and monitoring of customer satisfaction. You will perform comprehensive, articulate trainings and resolving customer support issues are two key components of the position. You will conduct initial and ongoing site, sponsor, and project staff training as necessary via teleconference, serve as primary contact for all site interactions and as liaison between users and Project Managers, and solicit, track, analyze, prioritize and resolve user feedback, complaints, and issues. You will also, assist the client/users in problem solving and provide consultation on study related activities and serve as a technical support for sites, Project Managers, Clinical Data Managers, contract Clinical Research Associates/Monitors, and other Outcome staff for project-related inquiries and issues. This position requires a Bachelor’s degree and the ability to learn quickly, multi-task and prioritize. You must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility. Excellent communication and interpersonal skills is also required.

Finance

Accounts Payable Coordinator

As the Accounts Payable Coordinator you will process all accounts payable, open mail and code invoices with G/L account numbers and create and maintain vendor records in Open Air and Great Plains Dynamics. You will handle vendor and employee inquiries by telephone and email, process client site reimbursement payments and reconcile contract / consultant employee’s invoices to electronic time sheets. This position requires 1-2 years relative accounting experience required, an Associate’s Degree in accounting or related degree, proficiency in Microsoft Word, Excel and general office software applications. Prior experience with Great Plains Dynamics preferred as well as some experience with foreign currencies and conversions is desirable. You must be able to work independently and good organizational, interpersonal, and communication skills required.

Business Development

Director of Business Development - Chicago & New Jersey 

This individual will be responsible in generating new business opportunities and maintain positive working relationships with existing clients. In this role, you will research, analyze and monitor prospective leads and trends in the biopharmaceutical and medical device industries to generate potential contacts, identify, qualify and follow up on potential leads to generate proposals and contracts for the company. You will write proposals and respond to RFP’s along with present the company’s capabilities to senior level decision makers to prospective clients. You will facilitate the transition of new projects, after contracting to the Professional Services team along with serve as the Account Manager for all relationships developed. The ideal candidate must have a Bachelors Degree or higher, 10 or more years of business development experience some of those years selling to clinical or medical affairs directors and having experience selling EDC solutions is preferable. Some travel will be required. The ideal candidate will be based out of Chicago.

Proposal Writer

As the Proposal Writer you will manage the analysis and completion of industry leading responses to Request for Proposals (RFP’s) and Requests for Information (RFI’s). You will assess appropriate RFP/RFI requirements and complete clear, concise and accurate responses that speak to the intended audience’s requirements. You will act as the focal point for assigned projects, managing an extended team including business development directors, professional services, scientific affairs, site management, legal, finance and senior management for successful completion of the assigned proposal. You will contribute to and maintain a working library of standard proposal content while constantly working with internal partners to maintain its relevancy and desired influence in the marketplace. You will ensure that all proposal documents are aesthetically pleasing, fall within the framework of the established brand identity and communication guidelines, produced to the highest quality standards, and delivered within deadlines. You will develop proposal-related tools that can be used as templates and models, provide ad hoc support on strategic marketing projects as needed and provide regular reports of project/program status and results. A Bachelor’s Degree in Marketing, Communications, Journalism or English is preferred. At least 3 years of experience developing and/or managing comprehensive proposals, preferably in a contract research organization or life sciences environment is required. Excellent written and oral communication skills, proficiency in MS Office and desktop publishing software products, the ability to work in a fast-paced environment, the ability to multi-task and work independently and experience with finished design and production process are desired.

Engineering  

Product Manager

The Product Manager develops and manages the technical product plan for specific product offering(s) including defining the market opportunity; conducting competitive analysis; market/customer requirements; conducting competitive analysis; value proposition and messaging; product vision, definition and roadmap. The Product Manager will work collaboratively with a cross-functional team to successfully execute the business/product plan and deliver on client product-specific requirements and project success. This position requires a Bachelors Degree with a Masters Degree preferred, 2+ years of technical project management with programming experiencing a plus. Prior experience in software product management, exposure to systems that support clinical research or healthcare is preferred. It is required that the candidate must also have the ability to lead a cross-functional team to drive product development, implementation and launch.

Associate Developer

The Associate Developer participates in the development of our web-based healthcare data management solutions. Position requires: Bachelor’s degree - Computer Science major preferred; familiarity with Java and/or Perl programming; familiarity with Oracle and/or SQL Server databases; familiarity with Apache and/or Tomcat web development and 2 or more years of computer programming/web development experience.

Developer

The Developer participates in the development of our web-based healthcare data management solutions. Position requires: Bachelor’s degree - Computer Science major preferred; 3-5 years experience with Java and/or Perl programming; familiarity with Oracle and/or SQL Server databases; and familiarity with Apache and/or Tomcat web development.

Software Architect

The Software Architect will spearhead software development activities for the company’s core product and will oversee architecture and design choices, technology selection, and the development and on-time delivery of software releases. The Software Architect will actively participate in defining and communicating the technology roadmap and product direction. This position requires a Bachelors Degree, Masters Degree preferred, a minimum of 8 years experience in the complete software development lifecycle and object oriented programming, web application development, SaaS and a multi-tenant environment. The ideal candidate will have experience working in the pharmaceutical, biotech or medical device companies with an understanding of FDA 21 CFR Part 11, HIPAA. Candidate must have strong verbal, written communication and interpersonal skills.

Desktop/System Administrator

As the Desktop/Systems Administrator you will monitor and support all internal information systems, provide user support for desktop issues, work closely with the IT Manager in administering Windows 2003/2008 AD infrastructure, develop and document methods to integrate and protect information systems. This position will support all Outcome systems, employees and contractors worldwide. This includes installing, diagnosing, repairing, maintaining, and upgrading all PC hardware and equipment to ensure optimal workstation performance. You will assist in developing long-term strategies and capacity planning for meeting future desktop hardware needs; deploy workstations, servers, printers, scanners, firewalls, encryption systems, and all host security systems; write technical specifications for purchase of PCs, desktop hardware and related products. A college diploma or university degree in the field of computer science and/or 3-6 years equivalent work experience is required. Experience supporting Windows XP, Vista and Windows 7 as well as desktop applications including MS Office, Adobe Acrobat, Windows Server 200X including DNS, DHCP, and ADS Structure is required. You must also have experience documenting and maintaining configuration and process information, knowledge of system maintenance systems including Symantec Anti Virus and have hands-on software and hardware troubleshooting experience.

Oracle Systems/Database Administrator

This position is the member of the Production Services team responsible for designing, deploying, configuring, maintaining and documenting the high-availability databases supporting our hosted clinical applications. You will evaluate and recommend available DBMS products after matching user requirements with system capabilities; develop and formulate standards, procedures, and conventions for database use; lead technical/programming staff to ensure database security from accidental or intentional loss or damage; and determine file organization, indexing methods and security procedures for specific user applications. You will also administer existing Oracle database instances, including RAC, ASM, schemas, tablespaces, statistics, initialization parameters, listeners, etc., and Provide technical direction for database design, maintenance, and administration. This position requires demonstrated expertise in the use of database management systems and related products from vendors such as Oracle, SAP, SAS, and IBM. A Bachelors Degree in Computer Science, Engineering or equivalent is required as well as 4-6+ years of related experience with Oracle RDBMS, OASM, Grid Control and associated tools. Also required is: 2+ years of Linux/Unix system administration skills and experience, extensive knowledge and experience building and maintaining Oracle Real Application Clusters (RAC), experience with SQL and PL/SQL programming.

Quality

Associate Quality Control Engineer

As the Associate Quality Control Engineer you perform validation testing for new and existing programs, including defect reporting and regression testing which includes functional, regression, stress, performance, scalability and system testing; participate in the development and review of Customer Specifications and Validation Documentation for releases of Outcome products under the supervision of a QC Lead Engineer; and file comprehensive defect reports in Outcome's issue tracking system for problems found during testing or specification review. You will act as the QC Lead Engineer for minor projects such as small updates under the direction and supervision of a Senior QC Engineer or the Senior Director of Quality; develop and maintain knowledge of all applicable Federal and State regulations regarding healthcare data such as HIPAA guidelines and FDA 21 CFR Part 11 and participate in customer audits of product quality systems as necessary. This position requires a Bachelor’s in Computer Science or related major, excellent communication skills and 0-3 years of experience. Also experience working with pharmaceutical, biotech or medical device companies and an understanding of FDA 21 CFR Part 11, HIPAA or ISO 9000 is desired but not required.

Scientific Affairs

Director of Biostatistics

The Director will lead statistical work and analysis for client projects worldwide, including participating in proposals, preparing and executing statistical analysis plans, evaluations of analyses and team deliverables as well as client consultation and presentations. This role is a key part of our scientific consulting team, and will have strong interface and collaboration with our epidemiologists, clinical project managers, business development directors, data managers, statistical programmers, etc. This person will help develop a technical team of programmers and analysts. The Director will recommend and conduct biostatistical activities in support of the design and completion of observational studies of comparative effectiveness and safety, as well as other observational pharmacoepidemiologic and outcomes research; apply knowledge and experience to complex and/or novel research questions in a way that adds value, design and conduct descriptive and inferential statistical analyses; write statistical portion of some study protocols and statistical analysis plans, develop sample size/power calculations, stratification, and, on occasion, randomization schema, consult on data collection methods and quality control to ensure availability and validity of required output for analysis. It is preferred that the ideal candidate have a doctorate in biostatistics, with a strong design and analytic track record and at least 10 years experience, experience working for or with pharmaceutical, biotech, medical device companies, or CRO; strong working knowledge of relevant statistical methodology (e.g., GLM, logistic regression, non-parametric and exact procedures , Bayesian analysis, and study size calculations); with knowledge of SAS a plus. The candidate must have strong oral and written communication skills, including the ability to convey biostatistical principles to colleagues with varying functional specialties and backgrounds, have extensive experience writing statistical analysis plans and summarizing the results of studies for the pharmaceutical or CRO industry. This person must also be technically proficient, as hands-on work, review and interface in technical client discussions is required.

Biostatistician                                                                                                     

As a Biostatistician you will work within scientific affairs, and closely with data management, regulatory & other functional groups to provide strategic input into observational research on the natural history of disease and comparative safety and effectiveness, to propose methodologically and statistically sound study design and data analysis plans to meet project objectives and regulatory requirements, and to conduct and supervise performance of analyses, evaluation and reporting. In this role, you will recommend and conduct biostatistical activities in support of the design and completion of observational studies, design and conduct descriptive and inferential statistical analysis, develop sample size/power calculations, and stratification or randomization schema along with consult on data collections methods and quality control to ensure availability and validity of required output for analysis. The ideal candidate will have a doctorate in biostatistics with a strong analytic track record and at least 5 years of biopharmaceutical experience. Candidates with an MS degree in biostatistics or statistics degrees and significant statistical and analytic experience may also be considered. Experience with general linear models, logistic regression, non-parametric and exact procedures, Bayesian analysis, and study size calculations along with having the ability to convey biostatistical principles is required. Also needed is a demonstrated ability to recommend plans for research design, strong working knowledge of relevant statistical methodology, experience in SAS and having the ability to work on multiple projects.

Director of Epidemiology

As a Director of Epidemiology you will work within scientific affairs, and closely with data management, regulatory & other functional groups to provide strategic input into biopharmaceutical post-marketing project development, to propose methodologically and statistically sound study design and data analysis plans to meet project objectives and regulatory requirements, and to conduct and supervise performance of analyses, evaluation and reporting. The ideal candidate will have a doctorate in epidemiology with a strong analytic track record and at least 5-10 years of biopharmaceutical experience, however candidates with lesser degrees and significant statistical and analytical experience may also be considered. This person must have strong oral and written communication skills and demonstrated ability to recommend plans for research design.

Research Associate

Outcome seeks a Research Associate in Scientific Affairs, to work closely with our epidemiologists, clients and other functional groups at Outcome in the design, conduct, analysis and reporting of observational research on the natural history of disease and comparative safety and effectiveness of medical interventions. This position would be located in Cambridge, MA. The successful candidate will organize and help conduct research, track project initiatives, and assist in data collection, management, analysis and reporting. This position requires a mature and flexible candidate who possesses cultural sensitivity and knowledge of the national and international public health community. Candidates must have a Bachelors degree, and having a Masters Degree or coursework towards a degree in Epidemiology or Public Health is a plus. Candidates must also have 2 to 4 years experience in public health, life sciences or a related research field, have excellent research and analytical skills including the ability to understand and synthesize medical and public health scientific information, excellent writing and communication skills along with the ability to work effectively in internal and external project teams. Experience conducting analyses with SAS and/or STATA is strongly preferred. Demonstrated multi-tasking, organizational skills with the ability to meet competing deadlines are necessary. Some travel may be required.

Medical Writer

As a medical writer you will work closely with biostatistics, epidemiology, data management, regulatory and other functional groups to provide support of biopharmaceutical post-marketing studies and registries. You will write and prepare scientific and regulatory documents that include study concepts, protocols, interim and final clinical study reports, safety reports and other periodic reports. You will contribute to planning and preparing abstracts, presentations and manuscripts and manage the process, i.e., coordinating all research and writing activities and timelines in conjunction with relevant internal and external stakeholders. This position requires substantial experience as a medical or scientific writer within the biopharmaceutical or healthcare industry with a minimum of a Bachelors degree. Candidates must have the ability to understand and interpret clinical and scientific data, including statistical output. Ideal candidates will possess knowledge of international and national standards regarding regulatory documents for submission and experience in preparing those documents. Excellent communication and interpersonal skills needs along with the ability to work on multiple projects with tight deadlines is critical. Experience with observational studies and post-marketing is a plus.

Outcome Europe