Associate Director Clinical Operations
Posted on: May 13, 2022
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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
Essential Duties and Responsibilities
The essential functions include, but are not limited to the
Lead/participate in program strategy meetings and contribute to the
operational strategy of responsible program/studies.
Establishes and builds Renegade.bio 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
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
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
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
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
Minimum of two (2) years of experience in Quality Assurance or
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
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: renegade.bio, Berkeley , Associate Director Clinical Operations, Healthcare , Berkeley, California
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