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.

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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.