Senior Manager, Global Trial Leader

Location:

Princeton, NJ

Company:
Sun Pharmaceutical Industries, Inc (USA)

The Global Trial Leader (GTL) provides global, regional or complex local management of clinical trials. Leader of the Clinical Trial Team (CTT) and point of contact from clinical operations for assigned trials. This role will be instrumental in providing operational oversight of assigned project(s) for end-to-end clinical trial management including start-up, execution, close-out, and study report finalization.

• Operational oversight of assigned project(s) for end-to-end clinical trial management including CRO selection for outsourced trials, start-up, execution, close-out, analysis and reporting.
  Strategic decisions for CRO identification and selection through RFP process
  Create a partnership with CRO and other vendors
  Influence CRO study team to effect change when necessary
  Recognize and elevate poor CRO performance
• Review of protocols and provide operational input, 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.
• 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.).
• Define and drive study timelines and milestones with Project Management
• In collaboration with relevant cross-functional team members, evaluates, refines and makes recommendations for various clinical operational aspects of study execution
• Address enrolment and retention issues, identify and implement actions to keep study on track
• Prepare & obtain approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
• Plan study activities and timelines and share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
• 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 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 like Protocol Deviations, Data entry & SDV status, Query status etc. and ensure quality in the study.
• 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.
• Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.
• Line Management for assigned resources.
• Complete assigned trainings & maintain updated personal training file.
• Follow up with data management team and investigator/site team for timely resolution of issues/data queries.
• Co-ordinate SAE reporting related activities with internal & external stakeholders.
• Initiate & track investigator, site and vendor payments.
• Follow up with the sites/vendors for all the pending documents

• Minimum 10 years clinical study management experience with at least 4 years direct multinational study management experience
• 3 + years in therapeutic area of company’s focus
• Ability to manage delegated aspects of assigned clinical trials
• Ability to manage CROs and Clinical Study vendors
• Bachelor’s level degree in life sciences, pharmacy or nursing
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements
• Proficiency in MS office including Word, Excel, PowerPoint and other applications
• Strong clinical study/project management skills
• Outstanding communication skills, both verbal and written
• Ability to work independently and prioritize duties
• Understanding of Electronic Data capture (EDC), CDMS, IRT etc.

The presently-anticipated base compensation pay range for this position is $150,500 to $183,500. Actual base…