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Associate Director Clinical Operations

Location: Berkeley
Posted on: May 13, 2022

Job Description:

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Position Summary
The Associate Director (AD) of Clinical Operations is responsible for assisting in the strategic planning, oversight and execution of all clinical trials across programs. The AD of Clinical Operations may also directly manage studies. Responsibilities include creating timelines and budgets, overseeing day-today operations, ensuring studies are conducted in accordance with regulatory requirements and within established timelines and budgets. Additionally, the AD of Clinical Operations will be responsible for leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The AD of Clinical Operations will assist in departmental process improvement initiatives and will supervise Clinical Project Managers, CRAs and other clinical support staff.

Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:

Lead/participate in program strategy meetings and contribute to the operational strategy of responsible program/studies.
Establishes and builds reputation and capability for successful delivery of clinical trials.
Responsible for the selection and oversight of external service providers, including CROs, consultants, and other vendors as necessary.
Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
Serve as an escalation point for Clinical Project Managers, Clinical Research Associates, or other study team support staff as needed.
Ensures operational processes, systems and standards are adopted and implemented consistently across trials.
Ensures the accuracy, completeness, legibility, and timeliness of the data reported via continuous identification of operational deficiencies, creation of corrective action plans, and development of best practices.
Develops and manages clinical trial budgets, providing ongoing financial reporting.
Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary.
Manages responsible studies within agreed timelines and budget in accordance with internal SOPs and GCPs..
Ensures all FDA regulatory standards are met in the conduct of all study-related activities within a CAP/CLIA laboratory as well as following GCP and ICH guidelines.
Coordinates cross-functional efforts to achieve study objectives and goals.
Identifies and communicates study issues that will impact budget, resources and timelines.
Participates in the preparation, review and finalization of clinical study-related documents such as protocols, CRF, ICF, -protocol amendments, Clinical Study Reports, regulatory submissions, and other publications as required.
Leads department initiatives and assists in the design and implementation of standardized work processes, ensures that all QA/QC measures are strictly followed.
Ensures documentation prepared internally or by CROs is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
Ensures Trial Master File is accurate and up to date.
Leads and develops staff, mentors more junior team members.

Minimum Qualifications (Knowledge, Skills, and Abilities)

Bachelor's and or Master's degree in a scientific discipline, RN, BSN degree or equivalent.
10+ years clinical research experience in an industry setting and a minimum of 7 years project-lead or management experience.
Experience leading studies for the development of IVD and nutraceuticals are a plus.
Knowledge of CLIA/CAP aseptic processing is preferred but not required.
Minimum of two (2) years of experience in Quality Assurance or Quality Control.
Previous experience managing clinical operations staff across multiple programs, including global experience.
Must have strong interpersonal skills needed to influence decision-making in a diplomatic manner.
Demonstrated effective team leadership abilities in cross-functional matrix teams.
Excellent oral and written communications with ability to present data to all levels of audiences.
Excellent analytical, organizational and time management skills with a proven ability to meet deadlines and handle multiple assignments simultaneously.
Ability to proactively identify and take appropriate initiatives to fulfill the requirements of the clinical trial operations.
Note: All offers of employment are contingent upon clear results of a thorough criminal background check.

Keywords:, Berkeley , Associate Director Clinical Operations, Healthcare , Berkeley, California

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