Senior Manager Real World Evidence RWE Operations
Senior Manager Real World Evidence RWE Operations
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$ 132000 - 165000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
The Senior Manager Real World Evidence (RWE) Operations will play a pivotal role in supporting both operational and research activities within the RWE and Prospective Research teams working with Global Health Research Analytics (GHRA) team. This individual will be responsible for driving forward the of Phase IV and Registry studies collaborating with internal and external stakeholders and ensuring efficient coordination of project timelines budgets and deliverables. This position requires a proactive individual with strong organizational skills strategic thinking and attention to detail.The Opportunity to Make a Difference
- Project management of internal and external research initiatives
- Manage daytoday activities for multiple Phase IV studies focused on Real World Evidence collection in patients receiving commercially approved products.
- Coordinate and execute activities related to registry and Phase IV study operations ensuring timelines budget and quality standards are maintained.
- Serve as the liaison with external collaborators providing highlevel customer service.
- Schedule and facilitate discussions with crossfunctional internal teams and external investigators.
- Coordinate activities with internal stakeholders including Clinical Operations Biometrics Regulatory Affairs and Patient Advocacy.
- Maintain and update RWE budget trackers managing agreement and purchase order development.
- Ensure timely tracking of studyrelated activities and overall project milestones.
- Maintain RWE SharePoint and Webpage to ensure documentation is up to date and accessible.
- Work with vendors on monthly project accruals and accurate forecasting in collaboration with project leads.
Research Support:
- Support product and team leads with primary and secondary data research activities.
- Assist in the development implementation and interpretation of Phase IV studies ensuring adherence to study timelines.
- Collaborate with crossfunctional teams to prepare documentation for regulatory submissions reimbursement agencies and other external organizations.
- Maintain knowledge of evolving epidemiological methods tools and data sources.
More about You
- Bachelors Degree in a life science discipline preferred; Masters Degree in Sciences Public Health Epidemiology Biostatistics or related field preferred.
- Minimum of 5 years of organizational experience in the biotech/pharmaceutical industry.
- Experience in collaboration with clinical operations and vendors for clinical/phase 4 studies
- Experience with Phase IV studies and research procedures such as clinical operations IRB submissions.
- Strong ability to multitask manage multiple projects and work in fastpaced crossfunctional teams.
- Previous project management experience with proven ability to identify issues provide solutions and ensure project timelines are met.
- Excellent organizational interpersonal and communication skills (verbal and written) with exceptional attention to detail.
- Strong proficiency in Microsoft Word Excel and PowerPoint.
- Strong proficiency in medical writing
Preferred Experience:
- Background in rare disease research and/or muscular dystrophy studies is a plus.
- Experience in managing study risk plans problemsolving and creative thinking within analytic and datafocused tasks.
Travel Requirement:
- This role is expected to travel less than 25 of the time.
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Senior Manager
Employment Type
Full-Time
