Post: Senior Clinical Scientist
Job Description
The Senior Clinical Scientist plays a crucial role within the Clinical Science function, providing essential scientific expertise to design and execute clinical studies and programs.
Position Summary / Objective
- Takes charge of implementing, planning, and executing assigned clinical trial activities.
- Acts as the Clinical Trial Lead for one or more trials.
- Provides scientific and clinical leadership to a team of supporting Clinical Scientists.
- Collaborates with cross-functional study team members and co-leads study team meetings.
- Supports clinical development planning in collaboration with Clinical Development Lead/Clinical Trial Physician.
Responsibilities
- Maintains a thorough understanding of assigned protocols and protocol requirements.
- Leads the implementation of all study startup/conduct/close-out activities.
- Evaluates innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead.
- Manages protocol and ICF development processes, including writing, reviewing, and adjudicating cross-functional comments.
- Conducts site-facing activities such as training and acting as the primary contact for clinical questions.
- Identifies clinical data trends and escalates questions to the Medical Monitor.
- Develops clinical narrative plans and reviews clinical narratives.
- Provides information required for the development of trial budgets and CRO scope of work.
Candidate Profile
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or equivalent).
- 5+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
- Strong communication and interpersonal skills.
- Detail-oriented with a strong sense of teamwork.
- Proficient in Medical Terminology and medical writing skills.
- Proficient critical thinking, problem-solving, and decision-making skills.
Key Competency Requirements
- Excellent verbal and written communication skills.
- Ability to collaborate effectively across functions and job levels.
- Quick assimilation of technical information.
- Initiative-taking and adaptability.
- Proficient planning/project management skills.
- Familiarity with Microsoft Word, Excel, PowerPoint, and Electronic Data Capture tools.
Additional Information
- Qualification: Degree in Life Sciences
- Location: Hyderabad
- Industry Type: Pharma / Healthcare / Clinical research
- End Date: 20th May 2024
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