Medical Scientist / Sr Medical Scientist

Job description

Description Medical Scientist / Sr Medical Scientist (Hyderabad Location) **Job Responsibilities** - JOB RESPONSIBILITIES - Location - Hyderabad office - Should be Phd/ Pharm D/ MBBS - Good English communication required - Min 1 yr of relevant experience - Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans. - Performs regular and ad-hoc medical review of data listings and data visualization as needed;analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. - Authors medical data queries and reviews query responses, approves query closure in association with Medical Director. - May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed. - Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed. - Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review. - Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates 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. - Attends Trusted Process meetings and may participate in internal and external audits. - Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology. - Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans. QUALIFICATION REQUIREMENTS - 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 is essential. - A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work. Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership. Understanding of scientific principles to assure effective and high-quality medical data analysis. Excellent written and oral communication skills. - Excellent computer skills: MS Office programs, spread sheets, presentations. - Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines. - Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment. Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.