Manager - Clinical Operations (project management team)

Clinical operations and project management of all assigned clinical trials for registration and data generation in India across different therapeutic areas based on India business needs.

Key Accountabilities (1/6)

Create the strategy and execution plan of clinical trials involving different stakeholders to provide forecasts on timelines and costs to the reporting manager for presenting it to senior management

• Project manage all Clinical Trials (using appropriate PM tools) during planning, execution of Clinical Trials and subsequent publications (as applicable)
• Review clinical trial master documents (Protocol, Patient Information Sheet, Informed Consent Form, Subject diary, CRF and questionnaire) and provide inputs
• Review and provide inputs for Statistical Analysis Plan(s) and Data Management plan (s)
• Assist the reporting manager in clinical trial budgeting and expense management
• Independently manage 2-3 clinical trials at any given point depending on the complexity of the project.
• Review agreements (master service, confidentiality disclosure and clinical trial agreement etc. as applicable)

Key Accountabilities (2/6)

Oversee, monitor and execute clinical trials based on the defined plan & strategy for completing it within the stipulated time both for in-house and outsourced project

• Provide oversight/review for following activities:
1. Translation and back translation of the PIS, ICF, Subject Diary and Questionnaire.
2. Ethics committee and DCGI submissions of clinical trial documents
3. Site identification and evaluation based on trial requirements
4. Logistics of clinical trial material and drug procurement.
5. Performing Site initiations as per project plan
6. Monitor and co-monitor ongoing clinical trials as per study monitoring plan
7. Offsite monitoring through electronic data capture of complex multi-center projects
8. Source Data Verification: Verify data entered in CRF/eCRF is consistent with source data.
9. Collect completed CRF in case of studies involving paper based CRFs
10. Ensuring timely transfer of paper CRF pages to DM vendor & coordinate in query resolution (both paper and eCRF)
11. Closing down study sites.
12. Ensuring accountability of clinical trial supply and drugs at sites handled

Key Accountabilities (3/6)

Oversee, monitor and execute clinical trials based on the defined plan & strategy for completing it within the stipulated time both for in-house and outsourced project.  

• Request the concerned team member for creating drug requisition, randomization plan, insurance and trial registration
• Support during regulatory inspection and provide timely response to the inspection observations (as applicable).
• Ensure logistics of clinical trial material and drug procurement (Products requiring import)
• Registration and regular update trials on Clinical Trial Registry of India
• Review activities and visit reports of reporting team members (if applicable)
• Maintain trial master file of allocated trials
• Provide inputs on Clinical study reports (CSRs)
• Coordinate for payment of investigator sites and vendors
• Work closely with CROs on outsourced trials with strong oversight to deliver project milestones within expected timelines, quality, and cost.

Key Accountabilities (4/6)

Identify, negotiate and manage the vendors (like CRO, Central Laboratory, Translation agency etc.)  for outsourcing work and complete it within the timeframe as specified in the strategy

• Identify and send request for proposal for outsourced activities to vendors. Share quotes received to reporting manager. Negotiate and close clinical trial study proposals with vendors.
• Assist reporting manager in defining payment schedule to investigators and service provider

Key Accountabilities (5/6)

Manage internal stake holders that are directly involved in the trials for its smooth conduct and other linked processes

• Manage internal stakeholder(s) pertaining to clinical trial processes including project management, legal, finance, marketing and regulatory teams (as applicable)
• Cross functional collaboration within the medical services department across various therapies (as applicable).

Key Accountabilities (6/6)

Identity, review and share inputs on the new products identified by the portfolio team 

Support reporting manager in clinical trial forecast, cost and defining trial complexity.

Major Challenges

• Dealing with multiple stakeholders across organisation and ensuring consensus on timely completion of task
• Ensuring performance of the investigators in terms of recruitment, quality, timelines and with limited resource in a competitive clinical trial scenario.
• Ensuring performance and deliverable from the vendor in line with Cipla quality standards and within approved budget.

Key Interactions (1/2)

Legal department for drafting of confidentiality and financial agreements as required

Medical services team for planning on trials required for supporting marketing needs as required

Purchase department for procurement of material & services required in conduct of clinical trials

Finance department on agreement with CRO for outsourcing project

Accounts department for clearing invoice received from different stakeholders (like Investigator (Research doctor), CRO, central laboratory etc.)

Regulatory affairs department for providing clinical study reports on past clinical trials or on regulatory queries received related to the registration of product

Manufacturing units to provide clinical trials samples on trials conducted by Cipla or arrange samples in IIT or IST

Corporate & India generics team for regulatory filing of documents on clinical trials

Key Interactions (2/2)

CRO for outsourced standalone or end to end outsourced projects

SMO for providing coordinator to investigator in Cipla sponsored or IIT

Translation Agency for translation of clinical trial documents

Printing Agency for printing questionnaire, subject diary and CRF required in clinical trials

Central laboratory for procuring services related to bloods investigations required in clinical trials

Investigators/Institutions for conduct of Cipla sponsored trials

Insurance company for procurement of insurance certificate required mandatorily by local regulatory body

Dimensions (1/2)

• Work on 2-3 clinical trials at any given point based on the complexity of the project
• Work towards capacity building by identifying 5-6 new clinical trial sites or investigators to contribute in the Cipla clinical trials.
• Work towards creating a network of 8-10 sites in therapeutic areas of special interest to deliver project within expect quality and time
• Support reporting manager in forecast of time and cost on 10-15 new products received from portfolio team

Dimensions (2/2)

Key Decisions (1/2)

Investigator identification

Vendor identification

Key Decisions (2/2)

Scientific inputs on clinical trials documents

Investigators Finalization

Vendor Finalization

Education Qualification

B Pharma/MSc/M Pharma/ Doctored. Preferably with a diploma or degree in clinical trials

Relevant Work Experience

• 8-10 years of experience in clinical operations and project management (CRO or Pharmaceutical Organisation).
• Should have experience and be able to independently handle early phase & registration clinical trials for India
• Should have a good verbal and written communication skills.
• Excellent knowledge of ICH GCP and Indian regulatory requirements.