Job description
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re 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 work-life 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: https://www.sarepta.com/join-us
The Importance of the Role
The Senior Clinical Trial Associate, Clinical Operations is an advanced professional who supports in the planning, execution, and management of clinical trials.
The Opportunity to Make a Difference
Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visit reports, etc.
Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
Performs quality checks on the study TMF with oversight of study Clinical Operations Lead (COL)
Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc.
Coordinates and tracks clinical trial equipment and supplies
Coordinates and tracks shipments of drug supply
Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead
Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation
May support and participate in departmental/cross-functional process improvement initiatives
Supports the trial team to produce and distribute study newsletters
Supports collection and updating of clinical trial insurance
Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
Serves as point of contact for 1 or more low to medium complexity vendors with oversight of study Clinical Operations Lead
Liaises with clinical trial sites as required
May assist in the coordination of Investigator Meetings and potentially present content
May assist the study Clinical Operations Lead with timeline maintenance and may lead smaller cross-functional team meetings with oversight of study Clinical Operations Lead
May support additional ad-hoc activities as agreed with the study Clinical Operations Lead
More about You
Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
Solid understanding of the responsibilities and needs of other functions in a clinical trial
Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
Ability to maintain confidentiality of proprietary information
A team player that takes initiative
Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within organization
Proficient written and verbal communication skills
Position may require some travel
Bachelor’s degree in life sciences or healthcare related field
4+ years’ experience in a clinical research related position
This role is remote in the USA with approximately 10% travel (once per Quarter)
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re 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.
#LI-Hybrid
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $107,200 - $134,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.