Associate Director, Clinical Operations
Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: September 23, 2024
Job Description:
Associate Director, Clinical Operations - - - - - - - - - - - -
- Sun Pharma Advanced Research Company Limited - - Princeton, New
Jersey -SummaryThe Associate Director, Clinical Operations is
responsible for Oversight of the Project Management team, Clinical
Research Associates, Clinical Trial Associates as well as
motivating, mentoring and training. This is a hybrid role and based
in Princeton, New JerseyResponsibilities Assigned:
- Oversee and manage all operational aspects of phase I-IV US
based or global clinical trials
- Act as primary point of contact for internal and external team
for planning, conduct, and reporting of assigned trials.
- Participate in vendor selection process with assigned PMO
representative. This includes proposal development, bid-defense
process, and contract review.
- Act as primary point of contact from clinical operations for
assigned trials.
- Oversee study start up activities of CROs (e.g. Site
identification, Feasibility, Site selection, Contract negotiation
and Clinical Study Agreement finalization, Translations, EC and
Regulatory submission, Site initiation etc.).
- Oversee, manage and assess vendor performance (timelines and
deliverables).
- Develop team and process for carrying out start up (site
identification, feasibility, selection, EC submission, contracting
and SIV readiness) for some sites in US for a faster FPI in a
Global or US only study.Budgets- prepare/review budgets for studies
managed in house and review professional fee and pass through costs
for CROs, SMOs, Investigators, and vendors, as applicable. Support
Functional Head in preparation of annual studies budget and
department budget.
- Manage and track study budget, project milestones, and
timelines throughout the life of the study and perform contract
reconciliation at study end.
- Plan study activities and timelines and share with
stakeholders, set up tracking tools for assigned trials & assess
progress as per pre-set timelines.
- Co-ordinate finalization of IP label & requisition. Forecasting
of IP requirement during the study and prepare IP requisition.
- Prepare/Review study plans for in-house/outsourced studies.
Train study team on trial documents, processes & assigned
SOPs.
- Plan and Facilitate vendor kick-off meetings and Investigator
Meetings for study.
- Meet investigators and key opinion leaders for assigned
trials.
- Drive subject recruitment for assigned studies and meet
predefined timelines.
- Prepare and implement Quality control plan in assigned studies
and ensure that clinical studies (in-house or outsourced) are in
compliance with ICH-GCP, SOPs, and applicable regulations.
- Coordinate with cross functional groups for required
deliverables.
- Oversee maintenance and timely update of Trial Master File
(TMF/eTMF) & Study folder and timely tracking of study
information.
- Review of study specific documents including status reports,
site visit reports & study plans and other reports i.e. Protocol
Deviations, Data entry & SDV status, Query status etc. and ensure
quality in the study.
- Perform Co-monitoring and vendor oversight visits to ensure
quality of trial conduct.
- Provide status update to stakeholders as per project
requirement.
- Lead process initiatives and improvements as assigned by the
function head -
- Contribute to development & finalization of key study documents
(i.e. protocol, Investigator brochure, informed consent document,
case reports form etc.)
- Ensure in-house trial closure after completion of all planned
activities and oversee archival of all study documents.Complete
assigned trainings & establish, maintain updated personal training
file.Secondary Responsibilities:
- Perform/Assist during
Audit/Assessment.
- Participate in meetings and discussions with CROs and support
teams.
- Contribute to interview process.
- Contribute to departmental activities including training,
initiatives & any other activities as assigned by FH.
- Participate in proposal development and in the bid-defense
process under guidance and supervisionEducation and
QualificationBachelor degree in life sciencesExperience7-10 years
of Clinical trial experience
Keywords: Sun Pharmaceutical Industries, Inc., Trenton , Associate Director, Clinical Operations, Executive , Princeton, New Jersey
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