Job Information
Sun Pharmaceuticals, Inc Manager - Clinical Science (Medical Monitor) in India
Job Title:
Manager - Clinical Science - Medical Monitor (RWE)
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, youll 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 others journeys.
YOUR TASKS AND RESPONSIBILITIES:
Lead the clinical research medical science related activities such as preparation of study synopsis, protocol and Clinical Study Report (CSR) for interventional, non-interventional and epidemiological real world evidence (RWE) studies
Collaborate with clinicians/KOLs to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis
Present the study proposals in Subject Expert Committee (SEC) regulatory meeting as applicable
Review and approval of patient eligibility in clinical trial through Interactive Response Technology system
Work with data management team to review data management plan, coding plan, SAE reconciliation, CRF completion guidelines, edit check specifications. Ensure timely review of study data extract and data cleaning activities for database lock and release of tables, listings, and figures (TLFs)
Coordinate with biostatistician to engage early with the study team to decide sample size, statistical analysis plan (SAP) apart from review of mock and/or blinded tables, listings, and figures (TLFs), and narrative and discussion planning for relevant documents
Prepare risk assessment plan based on the protocol of clinical study to identify and address the safety and operation related risk specific to study protocol
Training the study team on protocol and applied aspect of the protocol to clarify the relevance and criticality of each activity considering the study endpoints
Interact with investigator to resolve the queries related with protocol from the sites and Ethics Committee
Medical monitoring activity which includes eligibility assessment based on inclusion, exclusion criteria and detailed medical history, real-time review of study endpoint data and safety parameters
Review of AE and SAEs forms and provide review comments in timely manner
Planning publication activities for journal manuscript, abstract submission for conferences, and subsequent review of posters/oral presentations.
Job Requirements
Educational Qualification
MD (Pharmacology) or other relevant medical qualification with 0-4 years of relevant experience
Experience
Experience working in clinical science domain in different capacities as medical monitor for clinical trial/ medical expert for clinical development plan for products across therapies is desirable
Training in clinical trial methodologies, research design and ICH GCP
Thorough knowledge of New Drugs and Clinical Trial Rules 2019, GCP guidelines, ICMR guideline 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials Strong academic record with sound knowledge of research methodologies.
Competency Requirement
Integrity driven decision making skills
Sound functional knowledge in clinical research
Collaboration and 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
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).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.