Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.
Post : Global Trial Manager
Job Description
Oversight of CRO / other vendors and study management
• Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
• Assists in the management of CROs and other vendors to ensure project requirements are met
• Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
• Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
• Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
• User of systems and business technologies to document and track study and user progress
• Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
• Oversee TMF management and review TMF documents as necessary
Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)
• Work with QA for CAPA documentation and resolution
• Assists in forecasting of IP requirement during the study and prepare IP requisition.
• Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
• Assist in overall project planning and execution for clinical protocols
• This position requires approximately 10% travel to domestic and international locations
Collaboration with cross functional teams
• Coordinate with cross functional teams (e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
• Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
• Interacting with various internal and external teams to facilitate successful project completion
• Assist in managing study team meetings with both internal and external resources
Soft skills
• Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
• Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
• Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.
• Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
Candidate Profile
• Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
• 2 + years dermatology experience
• 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.
Additional Information
Experience : Minimum 6 years
Qualification : Bachelor’s level degree in life sciences, pharmacy or nursing
Industry Type : Pharma/ Healthcare/ Clinical research
Location : Mahakali - Office
End Date : 30th January 2025
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