Title:  Project Manager - Clinical Operations

Job Title:

Project Manager – Clinical Operations

Business Unit:

Medical Affairs & Clinical Research

Location:

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

ROLE AND RESPONSIBILITIES

· Lead a team of clinical research professionals and collaborate with cross-functional stakeholders for effective execution of interventional, non-interventional and epidemiological studies

· Develop and implement project plans, including timelines, milestones, and resource allocation

· Define project objectives, deliverables, and success criteria in collaboration with stakeholders

· Identify risks and develop mitigation strategies to ensure project success

· Allocate resources, assign tasks, and monitor team performance to ensure project goals are met CRO Managed Studies

 · Manage Contract Research Organization (CRO) for effective execution of clinical studies

· Identify potential investigators and sites for clinical studies in collaboration with CROs and India Medical Affairs team · Review of clinical trial documents for Ethics committee (EC) & Drugs Controller General of India (DCGI) and/or other regulatory submission (as applicable)

 · Vendor management as per Sun Pharma’s applicable policies & procedures

· Plan Investigational Product and other related trial material requisition, procurement, and dispatch

· Ensure timely reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSAR) to regulatory authorities and reporting of SAEs to all sites and investigators

 · Ensure training of CROs on Sun’s Pharmacovigilance (PV) practices.

In-House Managed Studies

· Site feasibility, potential investigator identification and development of study budgets for each study

· Finalization of investigators, sites and execution of Confidential Disclosure Agreement (CDA) and study related contracts

· Plan and conduct Investigator’s Meeting if needed

· Submission of study documents for EC permission for respective study across centers

· Work with R&D teams and facilitate Investigational Product (IP) procurement and ensuring streamlined auditable trial supplies to respective sites

· Overseeing & documenting IP dispensing, inventory management & reconciliation

· Site selection, Site initiation, Site monitoring and Site close-out activities

 · Investigator and site personnel training on Study protocol, procedures and GCP principles

 · Ensure timely recruitment of trial participants and subsequent efficient and effective data management

 · Ensure regular site monitoring visits as per plan, source data verification, informed consent form review, case report 

     form review, investigational drug accountability, and adverse event review for  c ompleteness, accuracy, consistency, and compliance; identify deficiencies and discrepancies, and provide remedial training and/or initiate corrective action as required

· Ensure timely reporting of SAEs, SUSARs and reporting of SAEs to all sites and investigators in alignment with regulations and Sun’s PV policies

· Coordinate project meetings and finalization of monitoring visit reports

· Risk identification, analysis and Corrective and Preventive Action (CAPA) for sites not meeting expectations as per plan

· Co-ordinate with in-house or CRO partners for data management, statistical analysis & statistical analysis report

· Lead & guide data query resolutions in coordination with sites and data management team

· Management of the trial budget(s) and maintenance of the accounts.

Job Requirements

Educational Qualification

Minimum qualification requirement is to have Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research

Experience

5-10 years’ experience in a CRO/Pharma/Biotech organization in clinical trial operations.

Related Experience

· Experience in handling large clinical trials with multiple sites for different therapeutic areas

· Thorough Knowledge & experience of remote and risk-based monitoring will be of added value

· Must have experience in handling audits & inspections

· Training in clinical trial methodologies, research design and ICH – GCP

· Thorough knowledge of New Drugs and Clinical Trial Rules, 2019, GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials

· Strong academic record with strength in research with knowledge of research methodologies

· Experience of working in matrix business environments preferred

· Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards

COMPETENCY REQUIREMENT

 · Integrity driven decision making skills

 · Sound functional knowledge in clinical research and operations

· Collaboration and teaming with ability to work in a matrix environment

 · Strategic thinking & sound analytical skills

· Big picture orientation with attention to detail

· Sense of urgency & desire to excel

· Self-awareness and adaptability to work in a matrix environment

 · Result oriented and performance driven

· Excellent interpersonal & communication skills to effectively interact with a broad range of audience

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).