Roles and Responsibilities
Senior Manager - Clinical Development- reporting to Lead- Clinical Development and Planning
- Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in development programs (all stages of development).
- Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
- Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.
- Present protocol and scientific results to multidisciplinary teams and key partners
- Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.
- Support and contribute to medical monitoring of trials
- Lead development of quality metrics and data review plan for assigned studies
- Assist in planning for and participate in investigator and coordinator meetings.
- Actively engage and integrate external academic and clinical trial expertise and resource to enhance quality and delivery of experimental and clinical development trials.
Education, Qualifications, Skills, and Experience:
- MD with 4-6 years of industry experience in Pharmaceutical Industry or CRO environment in clinical development, preferable experience of supporting early clinical development/ Drug development (phase 1 and Phase 2 studies). OR MBBS/MD (Pharmacology) freshers
Skills highlighted with ‘‘ are preferred keyskills
PG:Medical-MS/MD in Any Specialization
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