Senior Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Support the Clinical Program Manager with the setup of regional CROs and vendors.

• Collaborate with the Global CRO to guarantee site training and prompt initiation with the EMEA CTM.

• Manage daily interactions with CROs and trial-site contacts, identifying potential issues at EMEA sites.

• Ensure timely completion of deliverables, resolve issues, and communicate escalations to the Clinical Program Manager.

• Lead the strategies for EMEA regional regulatory submissions and package assessments.

• Identify operational challenges and devise solutions to maintain the study execution timeline.

• Assist with site selection, study implementation, and ongoing site management in the EMEA region.

• Conduct site visits alongside CRO CRAs and assess regulatory documents for compliance.

• Aid in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, clinical study reports, and investigator brochures.

• Evaluate CRO CRA trip reports.

• Maintain study timelines effectively.

• Coordinate the review of data listings and interim/final clinical study reports, including addressing data discrepancies.

• Provide regular updates on study progress to internal stakeholders.

• Maintain and review Clinical Operations databases and document repositories, including the study TMF.

• Carry out assigned administrative tasks.

• Mentor junior team members and contribute to enhancements in operational processes.

⛳️ Requirements

• A minimum of 6+ years of relevant experience with a BS or BA in a relevant scientific field, or at least 6+ years of experience with an RN (2 or 3-year certificate).

• Relevant experience in clinical trials within the pharmaceutical or healthcare industry, or equivalent experience.

• Required experience as a regional lead for ex-US (preferably in Europe).

• Exceptional attention to detail, along with strong verbal, written, interpersonal, and presentation skills.

• Familiarity with standard medical/scientific terminology.

• Proficient in Word, PowerPoint, and Excel; advanced knowledge of Excel is preferred.

• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials is desirable.

• Ability to engage in departmental or cross-departmental strategic initiatives with general supervision.

• Willingness to travel up to 25% of the time.

• Strong understanding of the EMEA regulatory landscape, submission processes, and timelines, including EU CTR, MHRA, and ANSM.

• Previous experience in a small to mid-sized biotech or sponsor-side environment is preferred.

• Must possess valid travel documents that can be obtained.

🏝️ Benefits

• Company bonus based on individual and company performance.

• Long-term incentive compensation.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Group legal insurance.

• Critical illness insurance.

• Identity theft protection.

• Pet insurance.

• Auto/home insurance.

• Sick time policy.

• Flexible vacation policy.

• Parental leave policy.