Sr Associate eCOA Manager
About The Position
Rangam is seeking candidates for a Direct Hire role as a Sr Associate eCOA Manager with our client Pfizer, one of the world's largest pharmaceutical companies. Seeking candidates in Cambridge, MA or willing to relocate. Use Your Power for Purpose Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy. In this role, you will: As part of the Clinical Data and Information Sciences (CDIS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Senior Associate, eCOA Manager, Clinical Data Collection Strategies is responsible for assisting in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and other related Patient technologies throughout Pfizer Research & Development. The position would work as a member of the Patient Data Strategies (PDS) team in helping clinical study teams use assigned patient data technologies. The role will be required to take ownership of sub-projects within the overall initiative, engaging a variety of stakeholders and customer groups to ensure study teams are enabled to implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk. Consideration of technologies allied and parallel to eCOA would also be required. This role demands the ability to work both autonomously on assigned work items, as well as being a member of a strongly interactive team. Skill set of potential candidates may include familiarity in the following areas: Mobile Technologies, Mobile App usage and Deployment, PRO technologies, eConsent, Medical Devices, Vendor relationship Management, Process Management, Change Management
Requirements
- Bachelor's degree or equivalent in a scientific discipline required.
- Minimum 3-5 years of experience in the Pharmaceutical industry including an understanding of the drug development process
- The candidate will have significant eCOA and/or trial management experience with technical expertise in eCOA.
- Strong experience developing standards strategies and leading implementation
- Experience in eCOA study design
- Demonstrated experience of project, vendor management
- Practical experience interfacing and achieving concordance with multiple stakeholders
- Ability to think critically and understand complex eCOA Study Design
- Strong written and verbal communication skills, leadership, decision-making, influencing and negotiating skills
- Knowledge of clinical research, FDA, ICH, CGP, related regulatory requirements, CDISC
Nice To Haves
- Master's degree in Statistics, Computer Science or related field or equivalent experience preferred.
- Master's degree
- Relevant pharmaceutical industry experience
- Experience using data visualization tools
- Proficient experience using commercial clinical data management systems and/or EDC products
- Strong analytical and problem-solving skills
- Ability to work collaboratively in a team environment
- Excellent organizational and time management skills
Responsibilities
- Assisting in the implementation and management of Electronic Clinical Outcome Assessment (eCOA) and other related Patient technologies throughout Pfizer Research & Development.
- Work as a member of the Patient Data Strategies (PDS) team in helping clinical study teams use assigned patient data technologies.
- Take ownership of sub-projects within the overall initiative, engaging a variety of stakeholders and customer groups to ensure study teams are enabled to implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory risk.
Benefits
- a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
