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Reports To: Director, Clinical Operations
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Clinical Study Manager will be responsible for the conduct of clinical studies and data collection and review, monitoring adherence to protocols, and all activities related to study completion. The Clinical Study Manager will interact internally and externally with members of cross functional study team, and, externally with service providers, investigational site personnel, and others involved in the conduct of the business.
Duties and Responsibilities Include But Are Not Limited To:
- Provides management of clinical research studies across all functional areas of the drug development process.
- Oversees and coordinates the operational aspects of new and ongoing clinical studies to ensure corporate goals of time, cost, and quality expectations are met.
- Assures that clinical studies are compliant with ICH/GCP.
- Works primarily as a member of the project team and individually as tasks dictate.
- Supervises Clinical Research Associates (CRAs) as needed – provides guidance and training.
- Works within clinical development and other functional areas to develop protocols, CRFs, ICFs, and other study related documents.
- Oversees preparation of RFP’s and prepares bid templates to facilitate selection of the CRO’s/vendors.
- Collaborates with counsel to negotiate and draft research contracts and agreements with CRO’s/vendors and clinical study sites, as needed.
- Prepares the project plan/timelines and monitors against project progress; ensures project activity compliance with plan. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc. Takes corrective action where necessary.
- Develops and maintains standard operating procedures (SOPs) for Clinical Development that facilitates the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards.
- Liaises with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed.
- Performs study risk management and implements mitigations.
- Performs other duties as required.
Desired Knowledge and Abilities:
- Must have a demonstrated track record of effective clinical conduct of clinical studies.
- Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
- Site selection
- Study initiation procedures.
- Clinical monitoring functions.
- Drug safety and regulatory affairs issues.
- Data flow from sites to data processing, review, and resolution.
- Analysis and report generation.
- FDA regulatory requirements (i.e. GCPs, CFRs, etc.). Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
- Effective communication and interpersonal skills.
- Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
- Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or project requirements.
- Computer skills should include proficiency with Microsoft Office suite of software.
Education & Experience:
- Bachelor’s Degree required (oncology experience preferred).
- Minimum 8 years’ relevant industry experience in clinical/medical research, nursing or pharmaceuticals/devices.
- Minimum 5+ years of prior clinical research experience.