Senior Clinical Trial Manager

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

📋 Description

• Manage clinical trial operations at site or country level, including oversight of vendors and external service providers.

• Act as the Clinical Operational Trial Lead when appointed, ensuring seamless cross-functional delivery from protocol synopsis to Clinical Study Report and trial results disclosure.

• Guarantee the delivery of high-quality outputs within established timelines, budgets, SOPs, GCP/ICH guidelines, and relevant FDA and state regulations.

• Assess and review monitoring visit reports, schedules, metrics, protocol deviations, issues, and action items utilizing Definium or CRO systems.

• Function as the primary sponsor contact for vendors, managing deliverables, patient recruitment, data collection, risks, timelines, and budgets.

• Maintain a strong understanding of therapeutic knowledge and familiarity with clinical protocols and projects.

• Update vendor scopes of service, budgets, plans, and timelines in collaboration with CROs and vendors.

• Supervise activities and deliverables of the CRO monitoring team.

• Support Quality Assurance during site audits.

• Review and contribute to the development of protocols, eCRF designs, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study-related documents.

• Oversee site contracts, budgets, vendor invoices, and accruals.

• Track and coordinate investigational products, clinical trial materials, and laboratory samples.

• Organize site round-table discussions and recruitment meetings.

• Engage in the development of departmental SOPs, systems, and processes.

• Ensure that the selection and setup of external service providers align with protocol specifications, budgets, and timelines.

• Uphold inspection readiness, data integrity, and overall data quality.

• Provide trial-specific training for trial team members and CRO personnel.

⛳️ Requirements

• A BS degree or equivalent is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• At least 6 years of clinical trial experience within the pharmaceutical industry or CRO is necessary.

• Proven experience in managing clinical trials or a prior senior CRA role, ideally in the psychiatric sector.

• Willingness and capacity to travel up to 20% of the time, as dictated by business requirements.

• Strong organizational capabilities and a keen attention to detail.

• Ability to thrive in a fast-paced and dynamic work environment.

• Knowledge of clinical research operations.

• Skills in project planning and management.

• Excellent communication and presentation abilities.

• Capability to oversee all aspects of clinical trial execution.

• Experience managing teams in a virtual setting is essential.

• Prior experience in vendor management is highly preferred.

• Outstanding leadership qualities with a proven track record of enhancing team productivity and cohesion.

🏝️ Benefits

• Comprehensive health benefits fully covered, including Medical, Dental, and Vision for you and your dependents.

• 401(k) plan with company match and vesting beginning after the first month post-start date.

• Flexible time-off policy.

• Generous parental leave policy.

• Enjoyable fringe benefits.

• Additional compensation opportunities, including bonuses and equity, may be available.