Career in Clinical Development Services Agency as Director - Government Job | Emoluments upto Rs. 1,45,000/- pm

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CDSAClinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute which is an autonomous institute created by the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India to strengthen the existing clinical trial / study capacity for affordable health care products in India and raise it to international standards. It is committed to strengthening and expanding the evidence base for healthcare nationally. CDSA has a national reputation for assisting academic investigators, bio-pharma entrepreneurs and innovative SMEs in the delivery of clinical trials and cohort studies throughout their life cycle from set up to closure. Over time, and building on current strengths, the mission of the Clinical Portfolio Section of CDSA is to become a centre of excellence that supports the conduct of Phase III/IV clinical trials and epidemiological studies of national importance.

Post : Director Medical Affairs –One Position

Age Criteria : Up to 45 years

Emoluments : Up to Rs. 1,45,000 /- per month consolidated (Salaries under

Duration : One year and likely to be continued

Location : CDSA, Faridabad

Essential Functions
• Provide medical leadership on clinical trials and clinical study projects
• Serve as medical liaison to all stakeholders – funding agencies, investigators, project teams
• Assist in promoting and show casing the services/achievement’s
• Provide medical guidance throughout the life cycle of trials/studies

 Medical Affairs
• Provide medical leadership to clinical trial and clinical study projects
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings

• Edit responses to IEC and regulatory agencies on adverse events and Serious adverse events
• Review and edit regulatory and safety documents for clinical consistency with data and standard of practice
• Review and edit CSR for clinical consistency with data and standard of practice
• Review all documents assigned for scientifically/ medically relevant issues including drug safety
• Review and sign off technical documents written with respect to medically relevant matters with particular attention to those relating to drug safety
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents
• Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings)
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committees (DSMC) and other committees, clinical/ product development planning meetings
• Provide advice and support for site feasibility
• Attend and present materials at internal meetings and investigator meetings
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Assist in the preparation of client proposals
• Act as medical liaison with clients
• Assist in the development of DSMB charters
• Assist in the development of protocol specific procedure medical manuals
• Engage medical experts as consultants/ advisers in various therapeutic areas as per the need of research project
• Participate in business development activities
• Provide consulting services to assist in the development of new drugs or devices under the direction of the Head of Organisation
• Provide medical leadership in developing quality assurance programs

Medical Monitoring
• Performs the duties of Medical Monitor for all the clinical studies in which CDSA is involved
• Interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
• Edit clinical narrative reports describing the event; advise on individual subject cases as identified by the study team and identifying queries for the local monitors to complete.
• Ensure compliance with clinical safety and good pharmacovigilance practices and requirements
• Provide support in preparation of Periodic Safety Update Reports (PSURs)
• Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication),
• Assist the PI and DSM in establishing the presence or absence of clinically meaningful trends and, if noted, assisting in follow up as appropriate with the project team, sponsor, and Regulatory Authorities
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

Medical Writing
• Takes a leading role in preparing or contributing to the production of any type of clinical document, for either internal CDSA customers or external clients, for investigational drugs, biologicals, or medical devices
• Acts as mentor for less experienced Medical Writers and assists in their training and development.
• Participates in project teams and may provide service as an independent expert. May serve as writing lead and project manager for medical writing projects
• Responsible for developing and managing writing style guides, templates such as, protocols, investigator's brochure, clinical study reports, IND sections
• Proposes applications
• Provides and manages internal and external writing activities
• Responsible for developing or acquiring a document management system, establishing style guides, and generation of templates and processes
• Revise SOPs or suggest process improvements for consideration. May draft new MW SOPs for review and act as reviewer for MW SOPs, as assigned and appropriate.

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