HEAD CLINICAL DEVELOPMENT OPERATIONS ( Biologics)

Job Description

Qualifications and Experience: Masters OR Doctoral degree, MBBS /MD/ with 15+ years of experience in global trial management and operations. Reports to: Global Head, Clinical Development Operations Location: Bangalore Responsibilities

• Oversees/Manages the development process for critical study documents.
• Works closely with members of other functional areas to provide input on study-related
• documents and issues
• Provides guidance to the CPM during identification and evaluation of CROs and vendors.
• Reviews/Provides Inputs in identification, evaluation, and selection of investigators/sites.
• Ongoing assessment, evaluation and management of internal and external resources.
• Ensures support is provided by the CPMs for preparation of regulatory dossiers
• Ensures study supply requirements are met. This includes ensuring drug supply and ancillary supply management including import/export, labelling, tracking of expiration date and timely resupply for global/ local trials.
• Supervises clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and CD SOPs.
• Communicates with relevant global team members, other departments ( e.g.,Program Management, Regulatory Sciences, Quality Assurance) and external consultants to ensure study objectives are being met and provide the senior management with timely updates on progress and changes in scope, schedule, and resources.
• Supports in organizing investigator/ expert/ DSMB/ Data Review meetings relevant to the indication.
• Responsible for the quality of all study-related documentation to ensure that all procedures are followed in an appropriate and consistent manner.
• Ensures in-house review of EDC is performed (when applicable) by the Clinical Project Managers
• Ensures that delegated clinical operations personnel liaise with medical sciences and Pharmacovigilance to provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs.
• Ensures delegated clinical operations personnel liaise with Data Management to review data discrepancies and to ensure that data clarification forms (queries) are appropriately handled by the CRO and responded to by the site/investigator in a timely manner. Will assist in the review of queries to determine criticality of the DCF during data clean-up and lock process.
• Ensures subordinates and service providers manage and monitor study-related expenses to meet forecast.
• Ensures timely communication of any variances to budget forecast to the Senior Management.
• Ensures Clinical Operations support in the timely coordination and execution of clinical study reports.
• Supports in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings.
• Ensures annual IND/ 1B updates are completed in an accurate and timely manner.
• Provides Clinical Operations support to the Regulatory Affairs department.
• Manages in-house team of Clinical Project Managers to ensure execution of all studies in a timely and efficient manner.
• Provides leadership, training, and skill development support to the team. Will lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently.
• Serves as a representative on internal committees/teams for Clinical Operations or cross-functional activities.
• Visits sites for Co-Monitoring from Sponsor.
• Ensures risk management plans and contingency plans are available for assigned trials.
• Ensures development of clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs (CRO project manager & BD manager).
• Ensures key milestone dates for the trial, enrolment rates and delivery of timely and high-quality data from the trial are met by overseeing the trial and in coordination with the Clinical Project Manager.
• Ensures accuracy of trial information in all trial Registries such as Clinical Trials Registry - India (CTRI), Clinicaltrials.gov etc.
• Ensures support in Handling of Regulatory, Marketing or any other molecule-related queries.
• Mentors and provides guidance to new Managers in Clinical Operations who will be assigned specific reportees and projects, ensures oversight of these activities.

Interested candidates kindly send your updated CV to sufya@bvrpc.comSalary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, BiotechnologyRole Category: Medical ProfessionalRole: Clinical ResearcherEmployment Type: Full Time, Permanent ,

Keyskills :
risk management plansrisk management data managementclinical trials project managerstrial management senior managementskill deve