Senior Clinical Trials Manager
1 week ago
Position: Senior Clinical Trials Manager
Location: Palo Alto, CA (Hybrid – 3 days onsite)
Length: 6+ months
Job Description:
Our client is seeking a highly experienced Senior Clinical Trials Manager to oversee the planning, execution, and management of clinical studies. The ideal candidate will leverage their deep expertise in clinical trial management to ensure the successful completion of studies within regulatory compliance, budget, and timelines. This position requires a proactive approach to problem-solving, the ability to handle multiple complex projects, and excellent communication skills for collaborating with internal and external teams. The Senior Clinical Trials Manager will play a key role in overseeing site training, vendor management, and clinical trial operations with an emphasis on ensuring data integrity and study success.
Essential Duties and Responsibilities (but not limited to):
Assist in protocol finalization and manage all aspects of study execution, from planning through to completion, ensuring studies are delivered on time and according to established protocols.
Utilize operational expertise to streamline trial design and optimize study execution, identifying challenges and proposing effective solutions.
Manage relationships and contracts with Contract Research Organizations (CROs) and other vendors involved in clinical trials, ensuring deliverables are met.
Provide support for site training and educational interventions, ensuring compliance with study protocols and handling of biospecimens where applicable.
Collaborate with stakeholders to prioritize, manage, and track biospecimen acquisition and handling, ensuring compliance with timelines and study needs.
Ensure adherence to all regulatory guidelines, including Good Clinical Practice (GCP), ICH, and other relevant clinical trial management requirements.
Drive the collection of clinical data, oversee clinical trial database construction, and assist with audits to ensure data validity and integrity.
Develop and manage the clinical trial budget, ensuring financial goals are met, reviewing invoices, and approving them based on the approved budget.
Control and manage trial-related expenses according to company policies, ensuring cost-effective execution of studies.
Qualifications:
Bachelor’s degree (or higher) in a science or health-related field.
7+ years of clinical trial experience within a pharmaceutical, biotech, or CRO environment, with a preference for direct trial management and CRO oversight.
Strong understanding of GCP, ICH guidelines, and relevant regulatory requirements for clinical trials.
Experience with clinical studies involving siteless methodologies or virtual recruitment is preferred.
Strong organizational and business assessment skills, with a demonstrated ability to develop positive working relationships with both internal and external teams.
Exceptional written and verbal communication skills in English, with the ability to present and share complex information effectively.
Excellent ability to identify issues and find solutions in a timely and effective manner.
Ability to work in a fast-paced, startup environment and manage tasks independently while maintaining a flexible, solution-driven attitude.
Expertise in MS Office, clinical trial management software, and project management tools.
Detail-oriented with a focus on driving tasks to completion.
Strong commitment to making a positive impact in the field of cancer diagnosis and treatment.
Self-motivated and capable of working with minimal supervision, while thriving in collaborative environments.
Willingness to travel up to 20% of the time.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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