Global Trial Leader: End-to-End Clinical Study Delivery

SUN PHARMA; Princeton (NJ); On-site; USD 151,000 - 184,000; Full time

Job summary

The role emphasizes strategic CRO selection, protocol input, budget planning, and cross-functional collaboration to drive study milestones while maintaining quality and regulatory standards.

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• Participate in vendor selection. Oversee & assess vendor performance.
• 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

Skills

Clinical trial mgmt

CRO management

Vendor management

Project management

Communication skills

MS Office

EDC

Independent work

Bachelors degree

ICH/GCP knowledge

Education

Bachelor's degree

Tools

EDC

CDMS

IRT

Job description

The role emphasizes strategic CRO selection, protocol input, budget planning, and cross-functional collaboration to drive study milestones while maintaining quality and regulatory standards.