Clinical Scientist - Psychiatry (Sr Manager)

Overview

Provides scientific expertise to design and deliver clinical studies and programs, leading and executing clinical trial activities and collaborating with cross-functional teams and external partners such as Key Opinion Leaders (KOLs).

What you'll do

• Design and execute assigned clinical trial activities, working closely with clinical team members within the assigned project
• Serve as Clinical Trial Lead for one or more trials, or lead or support trial-level activities with the necessary supervision
• Co-lead study team meetings in partnership with the GDO protocol manager and collaborate with cross-functional study team members
• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents and amendments and present them to governance committee and development team meetings as required
• Conduct literature reviews
• Submit clinical documents to TMF
• Develop site and CRA training materials and present them at SIVs and Investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop a Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol, in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of regulatory documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses) and contribute to regulatory submissions

What you'll need

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field)
• 2+ years of experience in clinical science, clinical research, or equivalent
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short-range plans that are realistic and effective)
• Detail-oriented with commitment to quality
• Basic knowledge of disease area, compound, and current clinical landscape
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Intermediate critical thinking and problem-solving skills
• Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

Nice to have

• Appropriate for new entrants to pharma (post fellowship/new to industry)

Details

• Location: Hyderabad, TS, India
• Domestic and international travel may be required