Senior Clinical Trial Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Trial Manager: Lead day-to-day operations for assigned clinical trials with an accent on CRO/vendor oversight, trial execution, and compliance with ICH/GCP. Focus on end-to-end operational planning, monitoring integrity of clinical data, and driving cross-functional trial teams through closeout.
Location: US based remote position (preference for New England based candidates); ~20% travel to Headquarters in Boston, MA
Salary: $180,000 - $205,000
Company
is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases.
What you will do
- Own operational aspects of designated clinical trials, including CRO and vendor management.
- Manage study activities such as vendor evaluation/selection, country and site selection, informed consent materials, eCRF design/implementation, and core trial documents (protocols, study plans/manuals, IBs, CSRs).
- Identify, support, and escalate trial conduct issues to resolution.
- Lead or support cross-functional trial teams and coordinate internal stakeholders and external vendors through closeout.
- Provide regular trial progress updates (enrollment, eligibility, protocol deviations, AE reporting, and performance).
- Oversee clinical monitoring from site qualification through closure visits; support data review/cleaning and reconciliation (EDC, PROs, third-party labs) to enable timely database lock and accurate analysis.
Requirements
- BA/BS degree with 7+ years of combined experience independently managing clinical trial activities.
- Strong knowledge of ICH/GCP and regulatory requirements, with preference for experience in global trials and EU-CTR.
- Strong experience in the drug development process, including trial design, planning/management, and CRO/vendor oversight.
- Excellent verbal and written communication skills.
- Proven ability to work effectively across functions.
- Ability to travel ~20% as needed by business.
Culture & Benefits
- Comprehensive health, dental, and vision coverage; life and disability insurance.
- 401(k) match.
- Paid, gender-inclusive parental leave; education reimbursement; discretionary time off; commuting benefits aligned to working model.
- Remote role with periodic travel to the Boston headquarters.
Hiring process
- Interviews to assess clinical trial operations experience, compliance knowledge (ICH/GCP), and cross-functional collaboration.
- Discussion of trial management approach, CRO/vendor oversight, and ability to travel.
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