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.

Click on "Apply for a job" to search and apply for open positions.

Fulltime positions currently available (pick a section below):
Outcome U.S. Outcome Europe
Corporate
Human Resources
Finance
Data Management
Project Management
Client Technical Solutions
Clinical Site Management
Quality Assurance
Software Quality Assurance
Software Engineering
Professional Services
Data Management
Epidemiology
Biostatistics
Business Development


Outcome U.S.

Corporate

We have no openings for Corporate personnel at this time. 

Human Resources

We have no openings for HR personnel at this time. 

Finance

We have no openings for Corporate personnel at this time. 

Data Management

Senior Clinical Data Manager (Job # 1117049)

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 - Massachusetts & Illinois (Job # 1116752, 1118097)

The 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 position requires a Bachelors degree along with a minimum of 2 years experience in clinical data management. 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, 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.

Manager, Data Manager - Massachusetts (Job # 1117067)

Manager of Data Management will be responsible for assisting in managing all of Outcome's data management needs. As a manager you will provide supervision to members of the Data Management Team to ensure projects are being successfully executed on-time and within budget and all aspects of project administration and data coordination are conducted effectively. You will also serve as mentor to CRAs, Clinical Data Managers, SAS programmers to help train and impart knowledge of company procedures and appropriate methods of client interactions. You will manage clinical trials and patient registry programs through review, cleaning and auditing of clinical data and databases in compliance with Standard Operating Procedures (SOPs), client guidelines, contractual obligations and regulatory agency guidelines. You will also be responsible for developing and maintaining general data management SOPs and Working Practices (WPs) related to the data management needs of those projects.
4-year degree (BA, BS) with a science or health-related background is required as well as a minimum of 10 years experience in clinical data management with at least 4 years of experience in leading and managing data management projects. Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A is a plus.

Project Management

Technical Project Manager (Job # 1116762)

The Technical Project Manager is responsible for all aspects of project administration and data coordination for multiple large-scale, Internet-based outcomes studies. As a Project Manager you will act as the customer advocate throughout the project lifecycle, understand the contractual obligations to each client and ensure those responsibilities are met and support global project goals including any clinical aspects like site recruitment, patient recruitment, marketing and PR. You will also serve as the liaison between the clients and internal team to ensure project-specific information and ongoing updates are proactively communicated and attend off-site meetings and conferences, as needed. A Master’s degree or a Bachelor’s degree as well as 4+ years of Project Management experience in the healthcare technology setting is required. Candidates must have excellent communication and organizational skills and the proven ability to independently manage large-scale projects focused in healthcare and technology.

Project Coordinator (Job # 1202184)

Teh Project Coordinator will serve as an integral member of the project team, participating in client calls and internal project meetings, assisting with meeting management including contacting and coordinating team members for availability, documenting meeting agendas and minutes, facilitate issue resolution for escalated site issues, manage timeline and budget tracking and risk management.
Additionally will compiling study enrollment and status reports for clients, assemble and send site materials, including study binders, assist with development and distribution of site communications including newsletters webinars, coordinate and oversee Site Reimbursements in collaboration with Site Management team, Legal Customer Service and Accounting department and oversee Site Management team's efforts in managing site IRB/EC approval process and IFC process; filing documents, completing paperwork with sites as needed 
Requires a Bachelor's degree with 1-3 years project assistance experience, preferably in the clinical field. Proficiency with technological tools, especially email/scheduling and MS Office (including PowerPoint) and outstanding interpersonal skills, ability to handle multiple projects simultaneously and prioritize effectively, detail-oriented, excellent written and verbal communications skills.

Clinical Project Manager - Massachusetts (Job # 1116763), Illinois (Job # 1116764), San Francisco (Job # 1116765)

The Clinical Project Manager is responsible for all aspects of project administration and data coordination for multiple large-scale, Internet-based outcomes studies. Based on experience and advanced project management skills, PMs 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). Requires 2+ years of Project Management experience in health care, medical research or a technology setting is required as well as a Master’s degree or a Bachelor’s degree with equivalent experience. Candidates must have excellent communication and organizational skills and the proven ability to work independently and manage large-scale projects. 

Clinical Project Coordinator (Job # 1116756) 

The Project Coordinator will serve as an integral member of the project team, participating in client calls and internal project meetings. They will assist with meeting management including contacting and coordinating team members for availability, documenting meeting agendas and meeting minutes as well as managing incoming contracts. The Project Coordinator will also coordinate and oversee Site Reimbursements in collaboration with Site Management team, Legal Customer Service and Accounting department. A Bachelor’s degree and 1-3 years project assistance experience is required, preferably in the clinical field.

Technical Project Consultant (Job # 1118099)

Technical Project Consultant will define technical requirements, create/approve project specifications and manage project team resources in all departments to facilitate successful project delivery to the client. They will work with management to identify and prioritize documentation needs and create standard and custom EDC project requirement specifications. They will also act as a designated contact for documentation improvements for external and internal projects as well as client contact to facilitate successful definition of technical project requirements and resolution of EDC project issues.
This position requires Bachelors degree in engineering or computer science as well as superior written and verbal communication skills with an ability to write clearly and concisely and a strong attention to technical details. Experience should be either 2+ years of engineering or software development or 4+ years as a writer of high-quality technical documentation. 
 

Client Technical Solutions

Technical Project Manager (Job # 1201562)

The Technical Project Manager defines the technical requirements for EDC systems, manages project team resources in all departments, and communicates directly with clients to facilitate successful project delivery. Also develops documentation templates and best practices to enhance efficiency and effectiveness of technical requirements gathering process and provides mentoring to and manages Project Consultants. A Bachelors’ degree in engineering or computer science is required. Experience should be either 4+ years of engineering or software development or 4+ years as a writer of high-quality technical documentation.

 

Clinical Site Management

Clinical Research Associate II (Job # 1116757, 1201474)

As a CRA II you will lead study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals, study binders, patient contact material, etc.). You will also participate regularly in client calls; provide updates on study reports (site, enrollment, regulatory document, query, monitoring status, etc.); assist the client in problem solving and provide consultation on study-related activities where applicable as well as manage and track study progress on recruitment/site selection, site readiness, IRB/EC submissions, patient enrollment, etc. A Bachelors Degree, preferably in a health or life science concentration, with at least 3 years clinical research experience, in a pharmaceutical, biotech or CRO setting is required. A minimum of 2 years of independent clinical monitoring is preferred. 

Quality Assurance

Clinical Quality Assurance Manager (Job # 1116758)

The Quality Assurance Manager is responsible for leading the Quality Assurance function at Outcome, including ensuring company compliance with clinical processes and regulations, performing internal and external audits and following up on findings, developing and maintaining Quality Management System documentation, and training personnel in areas related to compliance. They will oversee internal training, including regulatory and compliance training of study personnel as well as serve as in-house consultant for understanding project-specific requirements regarding national, regional, local laws and regulations and ensuring compliance. A Bachelor’s degree, preferably scientific or health-related field as well as experience developing process documentation, performing process and documentation audits and working in a structured environment. A Minimum of 4+ years of experience in the Quality field within the life sciences industry is required.

Software Quality Assurance

Software Quality Assurance Engineer (Job # 1118160, 1118165, 1118164, 1118162)

The Software Quality Assurance Engineer will work directly with the Software Quality Assurance Team Lead to assure that the Outcome software applications have been adequately tested, validated, and meet the standards of product quality for product release.  A Bachelors degree in computer science or equivalent is required as well as 2 - 5+ years of Software Quality Assurance including preparing validation (test) plans, scripts and reports, running test scripts, reporting defects, and implementing SQA methodologies.  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.

Associate Software Quality Assurance Engineer (Job # 1118161)

The Associate Software Quality Assurance Engineer will work directly with the Software Quality Assurance Team Lead to ensure that all healthcare data capture programs have been adequately tested, validated, and meet the standards of product quality for product releases. You will perform validation testing for new and existing programs, keep contemporaneous records of test results and participate in the development and review of Customer Specifications and Validation Documentation for releases of Outcome products. You will also act as the SQA Lead Engineer for minor projects such as small updates under the direction and supervision of a Senior SQA Engineer or the Director of Quality.
B.S. in Computer Science or related major is required. 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.

Software Engineering  

Senior Oracle Application Database Administrator (Job # 1201524)

This position is the member of the Development team responsible for working closely with the software development team in designing, configuring and documenting the high-availability databases to ensure scalable and high performance of Outcome’s hosted clinical applications. Evaluates and recommends available DBMS products after matching user requirements with system capabilities. Develops and formulates standards, procedures, and conventions for database use. As part of the design and development of the clinical applications, guide and review file organization, indexing methods and security procedures. Requires demonstrated expertise in the use of database management systems and related products from vendors such as Oracle, SAP, SAS, and IBM.
Requirments: BS/MS in Computer Science or equivalent. Five+ years of Oracle application development. Extensive experience with all aspects of Oracle Applications 11i in a Linux environment. Strong in depth experience in database performance and SQL tuning. Must be very knowledgeable and experienced in underlying Oracle applications database architecture. Strong interpersonal and communication skills. Willing to participate as a member of a team-based environment. Must be able to communicate clearly and effectively, both verbally and in writing. Must be a motivated self-starter, able to work successfully with little or no supervision.

Senior Software Applications, Director (Job # 1117528)

The Software Applications, Director will lead the EDC client customized application solutions development teams. As part of a services organization, in this role, s/he is responsible for the planning, development, and delivery of the client focused, customized applications and solutions within budget and on time with a high degree of quality. As well as, provide leadership and oversight to all application development resources, execution of development processes and metrics collection and reporting including the implementation of development process improvements necessary to gain further efficiencies, scalability and quality. Deliver all client focused applications and solutions on time, on budget, and within quality standard targets. Review and inspect development team project plans and estimates ensuring consistency and accuracy. Monitor resource utilization and capacity ensuring efficiency and forecast future capacity needs working closely with CTS to ensure staffing availability to deliver projects as, when needed. Management by metrics - Implement standard department metrics to enable measuring productivity, quality and progress and managing to meet goals and objects set. Requires:Bachelor’s degree; MS preferred. Ten+ years of experience in hosted software delivery. Minimum of 5+ years managing multiple software delivery teams/projects. Proven success in leading technical teams. Technical experience as a software developer. Ability to manage multiple parallel projects, highly organized with great attention to detail. Client service focused, with direct experience interacting with clients and end users preferred. Experience with Oracle, Linux , and hosted web application development using Apache, Tomcat, and Java. Experience with database intensive, high performing, scalable application development. Experience within the healthcare industry preferred.

Director of Product Management (Job # 1116747)

The Director of Product Management will develop and manage the product plan across the product line including defining the market opportunity, conducting competitive analysis, capturing market/customer requirements, providing value proposition and messaging, and working with the product and management teams to define product vision, definition and roadmap. They 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. A Bachelor’s Degree in a technical discipline or business administration is required (MS or MBA is preferred), as well as 10+ years of experience in a product management role and 5+ years of experience in the healthcare industry with specific experience in one or more of the following areas: late phase clinical research, patient registries, quality initiatives, electronic health record systems, industry standards (HL7, CDISC, IHE, eMeasures).

Senior Software Engineer (Job # 1117892, 1118158, 1118159)

Senior Software Engineer will participate in all aspects of the development of our web-based hosted, healthcare data management solutions. Primary Responsibilities include design, development and enhancement of health care application solutions following software development best practice. Senior Software Engineer will work collaboratively with other departments including the client technical solutions, project management and software quality assurance testing teams in the definition and delivery of quality solutions that meet FDA 21 CFR Part 11 requirements.
Requirements: BS in Computer Science or related major; MS Preferred; 7+ years of experience developing Java/J2EE web-based applications on a Linux platform; Strong knowledge and experience with as many of the following APIs, extended components and frameworks as possible within the J2EE arena: Eclipse, Ant, JSP/Servlets, JDBC, JavaScript, Apache, Tomcat and test driven development using JUNIT; Experience with high volume SaaS application development; Strong SQL development experience, Oracle knowledge a plus.

Software Engineer (Job #1118101, 1118102, 1118103)

The Senior Java Application Developer is a member of the Application Development Team and participates in all aspects of the development of our web-based, hosted, healthcare data management solutions. They will work closely with other departments including the client technical solutions, project management and software quality assurance testing teams in the definition and delivery of quality solutions that meet FDA 21 CFR Part 11 requirements. A Bachelor’s degree in Computer Science or related is required as well as 5-7+ years of experience developing Java/J2EE web-based applications on a Linux system.


Outcome Europe

Professional Services

Senior Clinical Project Manager / Clinical Project Manager

As Project Manager you will be responsible for providing overall project management of multi-national Phase IV/Post-Market Surveillance Programs and Registries, including interventional and non-interventional studies, post-authorisation safety studies (PASS), and drug & disease registries. Representing the company and working within an international environment you will work with pharmaceutical, biotechnology and medical device industry to execute assigned studies and ensure agreed scope delivery. As Senior Clinical Project Manager will also have line management responsibilities. The successful candidate will have: A Medical or Life Sciences degree with Project Management experience, or at least 2 years in a Lead CRA position with a desire to advance in your career. The Senior Project Manager candidate should have at least 5 years of Project Management experience. Phase IV experience and EDC expertise is highly recommended. Proven ability to independently manage large-scale projects - with excellent communication and strong leadership skills. Fluency in English is required. Other languages would be an asset.

Principal Clinical Research Associate

As a Principal CRA you participate in the planning, design and execution of clinical trials to ensure post approval studies are conducted according to the intent of the Sponsor´s projects while working collaboratively with internal and external project team members, including recruitment and training of the CRA´s as well as site identification and selection. You coordinate sites including start-up activities; track all Ethic Approvals and all CRA activities; review protocol and assist with case report form design. You also develop study monitoring plans for assigned studies; track and report study site progress and mentor less experienced Clinical Research Associates. The ideal candidate must have a bachelor’s degree, preferably in a health or life science and at least 3 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring required. The person must be fluent in English.

Clinical Research Associate

As a Clinical Research Associate you will provide support to projects while ensuring adherence to regulatory guidelines, SOPs, and study protocols. You will 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; monitor study progress to assure compliance with protocol-requirements, regulations and Good Clinical Practice by conducting site visits as directed. You will also monitor and track patient enrollment and ensure the timely accurate and complete collection and submission of study data. The ideal candidate must have a minimum of a bachelor’s degree, preferably in a health or life science and 2 years’ experience in a Clinical Research Associate position; experience with Electronic Data Capture (EDC) preferred. The person must be fluent in English and German or Italian.

Site Management Associate

As a Site Management Associate you support physicians, nurses, pharmacists and other healthcare workers 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. Performing comprehensive, articulate trainings and resolving customer support issues are two key components of the position. The ideal candidate must have a bachelor’s degree, preferably in life sciences, be fluent in English and in at least one or two other languages.

Data Management

Clinical Data Manager

The 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 position requires a Bachelors degree along with a minimum of 2 years experience in clinical data management. 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, 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.

Epidemiology

Senior Epidemiologist-Western Europe

Positions open for experienced epidemiologists interested in comparative effectiveness, safety and Risk Management. Candidates should have sound methodological training and an interest in designing, conducting and analyzing studies that require data collection, including direct collection from health care providers and patients, and chart reviews. Senior epidemiologists develop study concepts and protocols, and lead the analyses and reporting, in addition to other consultative activities. 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. 

Biostatistics

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. 

Business Development

We have no openings for Business Development personnel.

Outcome Sciences' Niche Finds Market, Plans Hires

Meet the Outcome Team

Download the Outcome Careers Information Sheet