The role:The Senior Clinical Trial Manager (Sr. CTM) is a key leader within the Clinical Operations team and will report to the Associate Director, Clinical Operations. The Sr. CTM will be responsible for the end-to-end operational delivery of a study in collaboration with other study leads across the program. This includes providing strategic oversight of study execution, vendor management, financial accountability, and cross-functional alignment.
Key responsibilities:- Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out (including site activation, enrollment, study conduct, and close-out) under the guidance of the Associate Director, Clinical Operations.
- Partner closely with the Clinical Operations study leads on key decisions by providing recommendations, proactively identifying risks, and escalating critical issues with proposed mitigation strategies.
- Drive study timelines, deliverables, and operational plans, ensuring alignment with overall program strategy. Monitor study metrics, including data quality, protocol deviations, and site performance, and drive appropriate follow-up actions.
- Oversee and support regional study execution, including site selection strategy, site start-up, and study progress; ensure efficient and timely study start-up across regions. Oversee and participate in the review of informed consent forms and regulatory submission packages.
- Perform visits (PSSVs, SIVs, RMVs) as required to demonstrate appropriate oversight of CRO CRAs and study sites to ensure study procedure conduct is in accordance with the study protocol, SOPs, regulatory requirements, and study plans.
- Oversee CRO and vendor activities, ensuring performance aligns with study expectations, timelines, budget, and quality standards. Support budget tracking and vendor financial oversight.
- Support cross-functional coordination across Clinical, Regulatory, Data Management, Safety, and other stakeholders to ensure aligned study execution.
- Contribute to, or own the development of, key study documents (e.g., protocols, ICFs, CRFs, monitoring plans, CSRs); under the guidance of the Senior Director, Clinical Operations (or designee) develop operational documents such as vendor specifications, study plans, SIV materials, Investigator Meeting content, and protocol amendments.
- Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements, including timely TMF filing.
- Participate in study reviews, including data listings, protocol deviation review, TMF quality, and monitoring visit reports; identify trends and drive appropriate follow-up actions.
- Provide regular, structured study updates to internal stakeholders as directed by the Associate Director, Clinical Operations.
- Mentor and provide day-to-day guidance to CTMs, CTMAs, and other junior team members that may be providing study support or regional management.
- Perform administrative duties in a timely manner as assigned.
- Contribute to Clinical Operations process improvements and departmental initiatives, as requested by the Associate Director, Clinical Operations.
Required experience & skills:- BS or BA in a scientific discipline or an RN (2- or 3-year certificate)
- At least 6 years of clinical trials/operations experience in the pharmaceutical or biotechnology industry
- Proven ability to manage complex, cross-functional projects and timelines
- Experience as a regional lead (e.g., Europe, Americas, and/or APAC) on a Phase 3 (or large Phase 2) study required; study lead experience preferred
- Strong experience with CRO and vendor management, including oversight of performance and deliverables
- Excellent leadership, communication, and stakeholder management skills
- Strong organizational and time management skills
- Strong problem-solving skills, with the ability to anticipate risks and implement mitigation strategies
- Excellent attention-to-detail, interpersonal and presentation skills are a critical asset; high energy level, personal productivity, creativity and commitment
- Proven track record of mentoring and developing junior team members through coaching and knowledge-sharing; direct people management experience is a plus
- Strong written and verbal communication skills with a collaborative, team-oriented approach.
- Must be familiar with routine medical/scientific terminology
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency is a plus)
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
- This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable
Salary Range: $160K to $185K
This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.
