Job Number: 21131636
PROJECT MANAGER FOR ECOA IMPLEMENTATION
LAWRENCE TOWNSHIP, NJ
- The WWHEOR Patient-Reported Outcomes Assessment (PROA) team is responsible the creation of execution of clinical outcome assessment (COA) strategies in company clinical trial programs.
- As part of the PROA team, this role will drive the successful implementation of electronic COA (eCOA) measures in development programs by ensuring compliance with internal processes, fulfillment of PROA team responsibilities, and adherence to timelines.
- The Associate Director, PROA will serve as point person on the PROA team to address stakeholder questions and concerns, provide a consistent voice in managing timelines, and demonstrate accountability to PROA leads for timely and accurate implementation of assessment strategies.
- Fulfill PROA team responsibilities related to eCOA design and implementation.
- Responsible for providing input to eCOA supplier contracting, serving as company lead representative during kick-off and design meetings, providing input to the development of company eCOA standards, monitoring and adhering to vendor timelines, executing COA Management eCOA submissions, and training stakeholders.
- Coordinate with functional counterparts in the development and review of eCOA documentation, including data model specifications, project plans, user acceptance testing (UAT) scripts, device screenshots, site user guides and training slides, and data migration plans.
- Manage communications with functional stakeholders to ensure full alignment and understanding.
- Candidates must have a minimum of a baccalaureate degree (advanced degree preferred) in computer science, the health sciences, or a relevant discipline.
- The candidate should possess a minimum of 10 years of related experience, including a minimum of 5 years of pharmaceutical industry or CRO experience.
- Experienced with eCOA design and assessment strategies, industry implementation standards for eCOA, client assessment standards, eCOA technologies, common problems in eCOA vendor management, and impacts of design decisions on timelines .
- Experience in system validation and knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials .
- Be abreast of rapidly changing methodological and regulatory environment with regard to eCOA .
- Knowledge of the drug development process .
- Skilled in technical writing and technical documentation .
- Excellent interpersonal and communication skills, both written and oral.
- Ability to understand and communicate with matrix teams to achieve the company's vision of shaping the portfolio and securing and maintaining patient access .
- Ability to manage multiple priorities and projects as well as balance workload and timelines.
- Able to work in a fast-paced and dynamic environment .
- Ability to work effectively in small teams or independently .
- Ability to interact with and manage internal and external networks .
- Extensive project management experience, including demonstrated ability to manage teams to achieve on-time delivery of key milestones.
- Experience with electronic clinical outcome assessment (eCOA) technologies, processes, and procedures.
- Knowledge of decentralized trial procedures a plus.
- Knowledge of drug development process and involved functional roles/stakeholders.
- Excellent interpersonal and communication skills.
- Experience with regulatory guidance on implementation of digital technologies in investigational studies a plus .
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02147
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE