About This Role
This role involves working as a Medical Scientist or Senior Medical Scientist, primarily based in Hyderabad. The position focuses on developing medical plans, performing data reviews, and collaborating with various teams to ensure data integrity and subject safety.
Responsibilities
- Work with the Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
- Engage with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input for medical plans
- Perform regular and ad-hoc medical review of data listings and data visualization as needed
- Analyze data to identify risks and data patterns/trends and support documentation of medical reviews
- Author medical data queries and review query responses, approving query closure in association with the Medical Director
- Assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, and creation of Medical Review Summary report as needed
- Partner with Medical Directors for medical data review meetings and safety review meetings, including slide preparation as needed
- Manage project scope of work, objectives, and quality of deliverables to ensure project-specific milestones and timelines are met
- Serve as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
- Collaborate with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety
- Escalate ongoing and newly developed study concerns such as at-risk project deliverables and out-of-scope tasks to the project leads in a timely manner
- Attend Trusted Process meetings and may participate in internal and external audits
- Acquire basic understanding and knowledge of ongoing protocol designs and disease-related terminology and pathology
- Adhere to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs)
- Adhere to all enterprise policies, standard operating procedures, work instructions, and project plans
- Adhere to customer policies and standard operating procedures, as required in project plans
Requirements
- PhD, PharmD, or MBBS degree
- Minimum 1 year of relevant experience
- Good English communication required
- Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline
- Excellent time management skills to handle multiple tasks and meet deadlines while delivering high-quality work in a highly regulated and dynamic environment
