Job Details
Posted 18 June, 2026
Job Id: 628228
Study Start Up Oversight Lead
Job Description
Study Start Up Oversight Lead – Biotech Innovation
Are you a seasoned clinical professional passionate about advancing cutting-edge biotech therapies? Join our innovative biotech client as a Study Start Up Oversight Lead, where you’ll be at the forefront of accelerating clinical trial initiation and bringing transformative medicines to patients faster. This pivotal role offers the opportunity to shape the future of biotech research through strategic oversight, process harmonization, and expert leadership across multiple studies.
Required Skills:
- B.A. or B.S. in a scientific discipline; advanced degree preferred
- Minimum of 5 years of clinical research experience, with at least 3 years managing Study Start Up activities within a sponsor or biotech environment
- Proven track record in managing outsourced clinical trials, ensuring quality, timelines, and budgets are met
- Strong project management capabilities with proficiency in MS Project
- Advanced Excel skills
- Experience with Veeva CTMS and Study Start Up modules is highly desirable
- Comprehensive knowledge of international guidelines such as ICH-GCP; basic understanding of GMP and GDP
- Exceptional organizational, communication, and interpersonal skills
- Effective negotiator capable of thriving in a matrixed, collaborative setting
Nice to Have Skills:
- Experience working with CROs or investigator sites, including site management or monitoring
- Involvement in feasibility assessments, site contracting, budgeting, vendor setup, or informed consent processes
- Background in developing process templates, project materials, or implementing process improvements
Preferred Education and Experience:
- Bachelor’s degree in a scientific discipline; advanced degrees or certifications such as CRA, PMP, or equivalent preferred
- Extensive clinical research background emphasizing Study Start Up oversight in biotech or sponsor environments
Other Requirements:
- Proficiency in MS Project and advanced Excel
- Ability to lead cross-functional teams and foster collaborative relationships
- Willingness to support and develop process improvements and special projects
- Availability for strategic calls, including scheduled and ad-hoc meetings
Join our biotech client’s mission to revolutionize healthcare–bring your expertise in trial start-up excellence and help deliver life-changing therapies worldwide. If you’re ready to make an impact, apply now and become a key driver in innovative clinical research!
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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