Precision Point Staffing ™
Sr. Clinical Project Manager
Precision Point Staffing ™, San Francisco, California, United States, 94199
Senior Clinical Project Manager
Our client, an innovative biopharmaceutical organization headquartered in the San Francisco Bay Area, specializes in advanced antibody discovery and engineering. Their technology platforms span antibody‑drug conjugates (ADCs), biospecifics, and multispecifics, with a research focus on oncology, immunology, and neurodegenerative disorders. Supported by a multidisciplinary team of more than 100 professionals across R&D, regulatory, and operational functions, the company is dedicated to translating next‑generation biologics from early development into clinical application through agile, science‑driven execution.
As a
Senior Clinical Project Manager (SCPM) , you will take a lead role in managing oncology clinical programs from initiation through completion (Phases I–III). This position requires a balance of strategic oversight and hands‑on execution, ensuring that clinical trials are delivered efficiently, within scope, budget, and compliance standards. The SCPM will collaborate closely with internal stakeholders and external partners to maintain excellence in study conduct and data integrity.
Key Responsibilities
Direct all operational aspects of oncology clinical studies from startup to closeout.
Act as the primary liaison among internal teams, clinical sites, and external collaborators including CROs, vendors, and monitoring teams.
Develop and track study timelines, budgets, project plans, and risk management strategies.
Oversee preparation and review of study documentation such as protocols, informed consent forms, and operational manuals.
Support site selection, feasibility assessments, and relationship management throughout study execution.
Manage CRO and vendor performance, ensuring adherence to contractual deliverables and quality expectations.
Lead clinical team meetings, document decisions, and ensure timely follow‑up of key actions.
Contribute to process improvements and development of SOPs, templates, and operational tools.
Assist in readiness activities for regulatory audits and clinical submissions.
Provide leadership in a dynamic, resource‑conscious environment that values adaptability and teamwork.
Qualifications
Bachelor’s degree in Life Sciences or related discipline required; advanced degree (MS, PharmD, PhD) preferred.
Minimum of 5 years’ experience in clinical operations, with at least 3 years overseeing oncology trials.
Proven ability to manage global, cross‑functional clinical programs.
Demonstrated success in CRO and vendor management, including budget control and performance oversight.
Solid knowledge of FDA, EMA, and ICH‑GCP guidelines and general clinical development frameworks.
Strong communication, leadership, and organizational skills within collaborative, small‑team environments.
Ability to manage multiple complex projects and adapt quickly to shifting priorities.
Familiarity with CTMS, EDC, and standard office productivity tools.
A proactive, solutions‑oriented professional who thrives in a hands‑on role and values collaboration.
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As a
Senior Clinical Project Manager (SCPM) , you will take a lead role in managing oncology clinical programs from initiation through completion (Phases I–III). This position requires a balance of strategic oversight and hands‑on execution, ensuring that clinical trials are delivered efficiently, within scope, budget, and compliance standards. The SCPM will collaborate closely with internal stakeholders and external partners to maintain excellence in study conduct and data integrity.
Key Responsibilities
Direct all operational aspects of oncology clinical studies from startup to closeout.
Act as the primary liaison among internal teams, clinical sites, and external collaborators including CROs, vendors, and monitoring teams.
Develop and track study timelines, budgets, project plans, and risk management strategies.
Oversee preparation and review of study documentation such as protocols, informed consent forms, and operational manuals.
Support site selection, feasibility assessments, and relationship management throughout study execution.
Manage CRO and vendor performance, ensuring adherence to contractual deliverables and quality expectations.
Lead clinical team meetings, document decisions, and ensure timely follow‑up of key actions.
Contribute to process improvements and development of SOPs, templates, and operational tools.
Assist in readiness activities for regulatory audits and clinical submissions.
Provide leadership in a dynamic, resource‑conscious environment that values adaptability and teamwork.
Qualifications
Bachelor’s degree in Life Sciences or related discipline required; advanced degree (MS, PharmD, PhD) preferred.
Minimum of 5 years’ experience in clinical operations, with at least 3 years overseeing oncology trials.
Proven ability to manage global, cross‑functional clinical programs.
Demonstrated success in CRO and vendor management, including budget control and performance oversight.
Solid knowledge of FDA, EMA, and ICH‑GCP guidelines and general clinical development frameworks.
Strong communication, leadership, and organizational skills within collaborative, small‑team environments.
Ability to manage multiple complex projects and adapt quickly to shifting priorities.
Familiarity with CTMS, EDC, and standard office productivity tools.
A proactive, solutions‑oriented professional who thrives in a hands‑on role and values collaboration.
#J-18808-Ljbffr