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Director, Clinical Operations
- Actalent (South San Francisco, CA)
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Job Description
Join a dynamic research and development company dedicated to harnessing advanced technologies to increase our understanding of the biology that controls lifespan. We aim to devise interventions that enable longer and healthier lives. We are seeking a contract Director, Clin Ops to manage the execution of clinical trials, ensuring regulatory compliance, quality, integrity, and timely delivery of clinical data.
Responsibilities
+ Lead activities in support of clinical research protocols from design to final deliverables, adhering to specified timelines and budgets.
+ Participate in the assessment, selection, and management of CROs, sites, and vendors, including performing qualification visits and reviewing project proposals.
+ Serve as the primary point of contact for internal and external partners to coordinate the delivery of clinical trials.
+ Provide oversight of site management through reviews of monitoring visit reports and tracking site metrics and deliverables.
+ Develop and manage study oversight plans independently, implementing risk mitigation strategies or corrective actions as needed.
+ Review and contribute to the development of clinical and regulatory documents, such as protocols, ICFs, CRFs, and CSRs.
Essential Skills
+ A BA/BS degree is required, with a minimum of 10 years of clinical trial management experience in an industry setting.
+ In-depth understanding of ICH GCP guidance, FDA, and EMA regulations.
+ Demonstrated ability to work independently and escalate issues appropriately.
+ Solutions-oriented approach to identifying and mitigating risks to project milestones, budgets, and quality.
+ Strong interpersonal skills to build and maintain positive working relationships with cross-functional stakeholders.
+ Detail-oriented with excellent verbal and written communication skills.
Additional Skills & Qualifications
+ Experience in early drug development (FIH through clinical proof-of-concept) is strongly preferred.
+ Proven ability to drive for results and support innovation.
+ A positive, can-do attitude.
Pay and Benefits
The pay range for this position is $130.00 - $150.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in South San Francisco,CA.
Application Deadline
This position is anticipated to close on Jun 13, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
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