Senior Clinical Trial Manager

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

📋 Description

• Implement Bicara’s clinical operations strategy for patient-focused, high-touch clinical trials characterized by adaptive and seamless designs.

• Ensure that trial deliverables adhere to timelines, budget constraints, operational protocols, and quality benchmarks.

• Create sections for study documents, study tools, guidelines, and training materials.

• Oversee clinical study materials and execute plans for issue resolution.

• Cultivate and maintain relationships with external collaboration partners.

• Identify, evaluate, and manage challenges and risks related to clinical studies.

• Supervise site identification and selection, enrollment strategies, clinical supply logistics, budget preparation, and trial execution.

• Track the progress of CROs and third-party vendors, ensuring regulatory compliance.

• Develop or amend CRO scope-of-service agreements, budgets, plans, and timelines.

• Contribute to the authorship of protocols, investigator brochures, informed consent forms, and other study-related documents.

• Engage in the design of Case Report Forms, user acceptance testing, and data monitoring efforts.

• Oversee CROs and clinical development teams to meet clinical development objectives and quality metrics for studies.

• Conduct oversight activities for CROs and third parties, including monitoring visit report assessments, data-quality evaluations, KPI reviews, and Sponsor Oversight Visits.

• Contribute to or draft clinical sections of regulatory documents and responses to inquiries from Health Authorities or Ethics Committees.

• Potentially supervise Clinical Trial Associates, including recruitment and supporting their career and professional growth.

⛳️ Requirements

• A Bachelor’s Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• At least 5 years of experience in clinical trial management within the pharmaceutical, biotech, and/or CRO sectors.

• Proven capability to manage global clinical trials across diverse geographical locations.

• Familiarity with clinical research operations and proficiency in computer applications.

• Strong skills in project planning and management, including oversight of CROs and vendors.

• Experience with global clinical trial management in a dynamic CRO-outsourced setting.

• Ability to lead global or regional teams in a virtual work environment.

• Excellent decision-making, communication, collaboration, and analytical abilities.

• Flexibility and capacity to function efficiently in a fast-paced environment.

• Effective leadership qualities and a proven track record in enhancing team productivity, cohesion, and quality outcomes.

• Experience in Phase 2/Phase 3 studies is strongly preferred.

• Experience in oncology studies is highly preferred.

🏝️ Benefits

• Short-term incentives, including cash bonuses.

• Long-term incentives, including equity-based incentive opportunities.

• Medical coverage provided upon hire.

• Dental coverage available upon hire.

• Vision coverage provided upon hire.

• A comprehensive benefits and wellness package.