Job Title: Manager - Clinical Science - Medical Monitor (RWE) Business Unit: Medical Affairs & Clinical Research Location: G11 A, Mumbai 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 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) and 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, affectionate or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. #J-18808-Ljbffr
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