Associate Director, Clinical Operations
Location: Emeryville, CA
Department: Clinical Development - MDS
The Associate Director, Clinical Operations will have direct oversight and/or plan and coordinate the conduct of clinical trials including protocol development, site and vendor assessment and adherence to GCP and other applicable guidelines and regulations. In addition, the Associate Director, Clinical Operations will partner with cross-functional stakeholders in Clinical Development to develop systems and procedures to assure uniform operation of all projects in the department. This position will be responsible for Clinical Operations deliverables and for updating management on the status of the assigned programs.
Essential Duties and responsibilities
- Provide oversight and leadership to cross-functional study team(s).
- Manages study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports.
- Manages study sites and trains clinical site staff to ensure protocol and regulatory compliance.
- Ensures SOP and regulatory compliance of staff.
- Responsible for CRO selection, development of RFPs, budget negotiations, and CRO management.
- Manages and provides oversight Clinical Study Vendors as required
- Responsible for clinical site budgets and contract negotiations.
- Develops and/or reviews study documents including monitoring plans, protocol deviation plans, TMF plans, Pharmacy Manual, Data Management Plans etc
- Participates in and provides input into the development of study protocols and clinical study reports, eCRFs
- Coordinates and participates in investigator meetings.
- Participates in monitoring visits, including Site Qualification and Site Initiation, as needed.
- Mentors and develops team members.
- Allocates resources and assigns tasks to meet corporate goals for timely initiation and completion of clinical studies.
- Coordinates clinical site audit activities including pre-inspection training at clinical sites.
- Establishes systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
- Develops Clinical Trial Master Files according to applicable domestic and/or international regulations and internal SOPs.
- Participates in other research related activities, as assigned.
Core Competencies, Knowledge and Skill Requirements
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint), CTMS, EDC, TMF and QMS systems experience
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
- Presentation skills necessary to meet the needs of various audiences.
- Strong team leadership experience and motivational skills.
- Ability to problem solve and use good judgement.
- Detail oriented
- Strong program management skills
- Bachelor’s Degree in scientific discipline (Advanced degree preferred; Neuroscience training a bonus)
- 10+ years of industry experience, including at least 6 years of experience specifically in management of CROs.
- 2+ years of experience managing direct reports preferred.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
- Up to 50% travel as required.