12 March, 2022
About the job
Primary Job Function
Oversee the departmental activities (projects, clinical operations budget, training requirements) of Abbott Pharma along with senior management
Core Job Responsibilities
- Accountable and responsible for all clinical operational deliverables of EPD (Established Pharmaceutical Division) India
- Coordinate with various cross functions team to ensure that deliverables both project and department level are met
- Understands the business requirements and develops project plans that supports organization agility with cost leadership.
- Oversight and guidance to team to ensure that projects are progressing as per deliverables i.e time, cost and quality
- Identify training requirements for the team and provide or facilitate the training needs of the team
- Guidance/Coordination with global stakeholders for globally managed interventional studies and local ICTs.
Direct Reports: Clinical Project Leads/Manager and Clinical Trial Assistant’s Indirect Reports: Clinical Trial Assistant’s
- To manage all aspects of the assigned responsibilities in the capacity of Head Clinical Operations and lead clinical operations for interventional and non-interventional studies.
- Give operational feasibility inputs on global interventional or medical affairs projects
- Give inputs on timelines and budgets to stakeholders (commercial team & medical affairs teams & global teams for ICTs)
- Oversee the planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines
- Reporting manager for CPL and CTA. To oversee the reportees and provide guidance and training to the reportees on required aspects (functional and soft skills).
- Accountable for ensuring legislation, ICH-GCP guidelines, Abbott EQD and Indian clinical research SOPs are maintained and followed on all studies.
- Developing/ reviewing clinical research documents, managing and training clinical team members.
- Vendor selection and negotiations
- Budgeting of clinical trials & communicate and get approval for out of scope activities impacting the budget and timelines of the study from all relevant stakeholders
- Communications on regular frequency with commercial teams, medical affairs, I&D as required
- Maintain appropriate communication with relevant functional areas as defined in section ‘Key internal and external interfaces’.
- Undergo and maintain training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to ICH-GCP, Abbott SOPs , processes and procedures, local SOPs, applicable regulatory requirements and study specific needs.
- Work with regional QA to plan a yearly audit plan
- Departmental matrix tracking in terms of budget, project deliverables, etc..
- Any foreseeable risk and delays are highlighted to the senior management.
- Guides the team and stakeholders for compliance to Global, Legal and Regulatory Framework for Medical Affairs Studies and global ICTs and local ICTs
MBBS / MD / M. Pharm/ B. Pharm/ MSc/ BSc with PGDCR
Minimum Experience/Training Required
Minimum 15+ years of work exp. in various capacities for clinical research in MNC CRO or MNC Pharmaceutical Company. Expertise in Medical Affairs, Pharmacovigilance etc. will be an added advantage.
Apply through this link