Clinical Operations Lead
- Biologics
- Hyderabad
- Clinical Operation
This vacancy has now expired. Please see similar roles below...
Lead CRO/Vendor Identification, Evaluation and Selection Process: Identify different CRO/Vendors and roll-out RFI and RFP
Assess RFI/RFP information and shortlist CRO for further Comparisions, discussions with HOD and senior leaders
Participate in vendor selection visits as Clinical Operations SME
Facilitate CRO/Vendor finalization
Strategic Inputs in planning and execution of clinical trials: Contribute in developing Clinical trial execution strategies/plan and also execute the clinical trials as per Clinical development strategies.
Define various recruitment initiatives in coordination with CRO/vendor.
Contribute in review and finalization of various clinical trial documents/plans like Study Monitoring Plan, project management/communication plan, RACI etc.
Provide clinOps inputs to various study documents viz. protocol, ICF, CRF etc.
Review various project specific Work orders, Change Orders, study invoices etc.
Ensure compliance of sponsor oversight plan by reviewing monitoring reports, CRF data, monthly listings/reports, perform onsite visits etc.
Contribute to various functional capability building initiatives Develop and review various SOPs, Work Instructions, study manuals
Consolidate lessons learnt and share best practices with cross functional teams
End to end vendor management: Build and maintain good working relationship with CRO/Vendor
Prepare and conduct F2F meetings with CRO on need basis
Attend various governance meetings (PTM, CPR, N-CC apex etc.) Participate in various governance meetings like Internal and External Project Team meetings, Data Management calls, CPR, N-CC apex meetings etc and other internal and external governance meetings.
People Management• Conduct goal setting, performance appraisals and mentoring/coaching for team members.
• Collaborate with HOD in manpower planning, recruitment activities and identifying training needs of team members.
• Provide training to team members on new processes when required
Education Qualifications Master /Bachelor Degree in life sciences or allied medical fields (e.g., B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D.) Experience Minimum of 12 years of clinical research/ operations experience of which at least 2 years in Biosimilar studies and 2 years of people management. Business Understanding: Understanding of biosimilar development, awareness about regulatory guidance's for the conduct of clinicals trials in India and other regulatory agencies, knowledge on Biosimilar Competitive Intelligence; Reasonable knowledge on technologies used in execution of Clinical trials (DM, IWRS, safety platforms etc.) :Negotiations, Cross Cultural sensitivities;
Different Therapeutic Areas (Oncology, Rheumatology, Dermatology etc.) ; Treatment options;
Technology Platforms, Basics of clinical development; Budget forecasting, Global Regulatory framework; Basics of Quality, IP supply and Managment, Vendor relationship management and governance.
Behavioral Skills: Ability to work in ambiguity; Strong Strategic and Execution blend; Ability to align cross functional teams for successful execution; Self-initiative and resilience; Excellent verbal and written communication skills, Good Planning, influencing and negotiation skills.
Latest jobs
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Digital Product management
Business Unit
Corporate
Location
Hyderabad
Description
Role Overview:As the Lead UX Designer, you'll be a critical contributor to our design philosophy. In your area of allocated responsibility, you'll ensure that design isn't just an afterthought but is
Reference
847227c5-a7a2-436c-9d88-328aaa20d8b3
Expiry Date
01/01/0001
Salary
Location
Pydibimavaram
Type of Working
Full Time
Job Family
Operation, Repair & Maintenance
Business Unit
GMO
Location
Pydibimavaram
Description
Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaini
Reference
e74fcad8-37f1-4d22-aff9-1390d3c29eb6
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
DPEx General
Business Unit
GMO
Location
Hyderabad
Description
Job Summary We are seeking a highly motivated and analytically strong Supply Chain Analyst to join our DPEx team. This role is pivotal in driving data-driven decision-making across key supply chain a
Reference
279ee572-225d-4b21-bf41-4ac5caa52464
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Finance Generalists
Business Unit
Corporate
Location
Hyderabad
Description
Description1.The person must be well versed with P2P, OTC and R2R operations and should be able to drive the process KPI's and SLA's with outsourced partners. 2.Should be able to generate MIS with in
Reference
0188d6f0-cafb-4f0b-b2e9-5ea6ee61af57
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
DPEx General
Business Unit
GMO
Location
Hyderabad
Years of experience
12 - 20
Description
Job Summary: The Principal DPEx OSD Manufacturing Ops will spearhead digital transformation initiatives and process improvements within the OSD Manufacturing Business unit. This role involves driving
Reference
872425cb-d88a-462a-aecf-7daf72c7e29f
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
New Product Launch
Business Unit
IPDO
Location
Hyderabad
Description
Job Summary We are seeking a dynamic and experienced Project Manager in Research & Development team for comprehensive project management support throughout the project lifecycle, including initiation
Reference
df6ef55f-f42e-42e7-a350-b9b101663156
Expiry Date
01/01/0001
Salary
Location
Delhi
Type of Working
Full Time
Job Family
Sales General
Business Unit
GG INDIA
Location
Delhi
Description
Job Summary We are seeking an experienced and proactive Area Sales Manager to oversee and drive sales performance in the designated area. The ideal candidate will be responsible for achieving area s
Reference
7922d6a6-aa01-47a3-9c1c-d08398d36af6
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Formulation R&D - OSD
Business Unit
IPDO
Location
Hyderabad
Years of experience
12 - 20
Description
Job Summary We are looking for an experienced Technical Lead in the Oral Solids Formulation Research & Development Department. This role encompasses new product ideation, successful product introducti
Reference
e3f1b999-ca2b-437e-91a3-ba034188281f
Expiry Date
01/01/0001
Salary
Location
Hyderabad
Type of Working
Full Time
Job Family
Formulation R&D - OSD
Business Unit
IPDO
Location
Hyderabad
Description
We are seeking a dynamic and experienced Scientist in Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to def
Reference
5e1abec6-02a8-42fa-9725-500748ab1369
Expiry Date
01/01/0001
Salary
Location
Visakhapatnam
Type of Working
Full Time
Job Family
Quality Control
Business Unit
GMO
Location
Visakhapatnam
Description
Job SummaryWe are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role
Reference
250cf489-7198-4bc6-bd7b-e16320d4bd6d
Expiry Date
01/01/0001
Jobs you have shown an interest in