Clinical Project Manager

Clinical Project Manager

Newark, CA - On- Site

$140,000 - $180,000

I am working with a Bay Area biotech seeking an experienced and highly motivated Project Manager, Clinical Operations, to drive the planning, execution, and successful completion of their clinical trials.

They are a pioneering clinical-stage biotechnology company dedicated to developing innovative small molecule treatments for inflammatory and metabolic and cardiovascular diseases. Their cutting-edge research and development efforts aim to provide patients with more effective and safer medications, transforming lives and advancing healthcare.

This role reports directly to the Sr. VP of Clinical R&D and the CEO, and is ideal for candidates with a strong track record in managing global clinical trials. The Project Manager, Clinical Operations, will work in their office in Newark, CA.

As the Project Manager, Clinical Operations, you will be responsible for full-cycle oversight of one or more clinical trials, ensuring all projects are executed within the timeline and budget. You will manage cross-functional teams and oversee CRO/vendors. You will ensure all clinical trial activities, including database clean up before database lock, are conducted in compliance with the protocol, standard operating procedures (SOP), good clinical practices (ICH GCP) and other applicable regulatory requirements. You will also monitor all the invoices and budgets from CROs and vendors. Strong initiative, communication, and follow-through are essential for this role. The ability to maintain confidentiality and operate with the highest ethical standards and professionalism are required.

Essential Duties & Responsibilities

• Responsible for end-to-end trial management.
• Participate in the development of protocols, ICFs, study plans, CRFs, patient materials, CSRs, and NDA submissions.
• Manage CRO interactions, including oversight of activities such as site management, site payment, sample logistics, clinical trial supply logistics, IP management, TMF, budgeting, and contract negotiations.
• Prepare and present metrics and updates to senior management.
• Proactively identify potential study issues/risks and recommend solutions.
• Participate in the CRO/vendor selection process for outsourced activities.
• Work with CRO to develop the scope of work and timeline and ensure performance expectations are met.
• Manage clinical monitoring activities, review monitoring visit reports, and oversee the follow-up on action items by CRAs.
• Participate in the development, review, and implementation of departmental SOPs and processes.
• Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings.
• Serve as a liaison and resource for investigational sites.
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure efficient operation.
• Perform other duties as assigned.

Core Competencies, Knowledge, and Skills

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust-building in all dealings are essential and required.
• Daily demonstrates a positive, "can do" and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Skilled in developing collaborative internal and external relationships.

Requirements

• At least 5 years of experience in clinical trial operations and a BS or BA in a relevant scientific discipline.
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel, and Project.

Travel, Physical Demands, and Environment

• Regularly required to operate standard office equipment.
• Ability to work on a computer for extended periods of time.
• Regularly required to sit for long periods of time.
• Regularly required to use hands to operate a computer and other office equipment.
• Close vision required for computer usage.
• Occasionally required to stoop, kneel, climb, and lift up to 20 pounds.
• Travel possible.