Clinical Project Manager - #1337094

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Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

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Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development.

The Sr. Manager will be responsible for the following:

• Act as a primary point of contact for internal/external team for planning, conduct, and reporting of assigned clinical trials.
• Team mentoring, training, and oversight of project team –Clinical Research Associates and Clinical Trial Assistants
• Oversee and manage all operational aspects of Phase I-IV US based or global clinical trials
• Oversee study start up activities (e.g. Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.).
• Prepare & obtain approval for clinical trial budget and for any change in the budget during the study.
• Participate in vendor selection with assigned Project Management Organization representative.
• Oversee, manage & assess vendor performance (timelines and deliverables)
• Initiate vendor contact, exchange contracts and negotiate costs for data management, monitoring, and central laboratory, as applicable.
• 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.
• Train study team on trial documents, processes & assigned SOPs.
• Arrange/Participate in kick-off meetings.
• Prepare/Review study plans & oversee compliance.
• Plan and conduct IM if required.
• Tracking of project finance & project milestones.
• Meet investigators and key opinion leaders for assigned trials.
• Drive subject recruitment for assigned studies and meet predefined timelines.
• Oversee & track regulatory & GCP compliance.
• Coordinate with cross functional groups for required deliverables.
• Oversee maintenance and timely updates 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 like Protocol Deviations, Data entry & SDV status, Query status etc. and ensure quality in the study.
• Perform Co-monitoring site visits and vendor site visits to assess quality and performance.
• Provide status update to stakeholders as per project requirement.
• Manage the vendors for outsourced services and activities to ensure timely setup & conduct and track their deliverables.
• Review of protocols, vendor proposals and other documents and lead initiatives as assigned by the function head & contribute to development & finalization of key study documents including 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.
• Line Management, team management and performance appraisal for assigned resources.

Secondary Responsibilities:

• Perform/Assist during Audit/Assessment.
• Participate in meetings and discussions with CROs and support teams.
• Manage managers & resources performing lead activities.
• Contribute to interview process.
• Contribute to Clinical Development Strategy.
• Contribute to departmental activities including training, initiatives & any other activities as assigned by FH.
• Participate in conferences & workshops.
• Participate in proposal development and in the bid-defense process under guidance and supervision.

Qualifications:

• BS in Pharmaceutical Sciences or other health related degree
• 6-8 years’ experience in clinical trial experience
• Excellent verbal and written communication skills