Job Description

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.

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).

More Info

Education