Senior Clinical Trial Manager

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

📋 Description

• Oversee the daily operational elements of assigned clinical trials or regions, which includes managing CROs/vendors, drug supply, and clinical site operations.

• Supervise high-impact vendors by managing timelines, contracts, invoicing, purchase orders, and forecasting activities.

• Direct the creation and upkeep of study documentation, encompassing study timelines, vendor management plans, risk management plans, informed consent forms, monitoring oversight plans, CRFs, study reference manuals, and dashboards.

• Lead or actively participate in Study Management Team meetings.

• Recognize study risks and devise as well as implement mitigation strategies.

• Oversee the Trial Master File, conduct completeness reviews, and maintain the essential document list.

• Assist in study budgeting, which includes reviewing clinical trial financial accruals.

• Manage direct reports effectively.

• Represent Clinical Operations in various initiatives and potentially take a leadership role in these projects.

• Ensure all study start-up and close-out activities conform to SOPs and relevant clinical trial regulations.

• Guarantee that high-quality deliverables are achieved within established timelines and budget constraints.

⛳️ Requirements

• A Bachelor’s degree or its equivalent is mandatory (a background in a scientific or healthcare discipline is preferred).

• Generally, 8 years of direct experience in Clinical Research is needed, with a preference for international experience from study start-up to close-out.

• Must be fully capable of independently leading all facets of a clinical trial.

• Proven ability to lead cross-functional teams effectively.

• Strong planning, organizational, and communication skills are essential.

• Ability to manage multiple tasks and deadlines while identifying risks and issues, taking appropriate actions as necessary.

• Self-motivated with the capacity to develop solutions for a variety of complex problems that require thorough analysis of various factors, including inter-organizational impact.

• Capability to establish and maintain positive relationships with management, peers, vendors, and clinical sites.

• Willingness to travel up to 10% may be necessary.

🏝️ Benefits

• Generous vacation time along with public holidays recognized by the company.

• Volunteer days are available.

• Long-term incentive and employee stock purchase plans or similar offerings.

• Employee wellbeing benefits provided.

• Fitness reimbursement options.

• Tuition sponsorship opportunities.

• Plans for professional development are in place.

• Annual bonuses and equity incentives are offered.