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Key Responsibilities and Required Skills for Clinical Scientist

💰 $90,000 - $140,000

Clinical ResearchLife SciencesDrug Development

🎯 Role Definition

The Clinical Scientist is a mid‑to‑senior level role responsible for planning, executing and interpreting clinical studies to generate high‑quality evidence in support of product development and regulatory submissions. This role partners with cross‑functional teams (clinical operations, biostatistics, regulatory, safety, medical affairs, translational sciences and external CROs) to design protocols, ensure subject safety and data integrity, produce clinical study reports and contribute to clinical development strategy. The Clinical Scientist applies therapeutic area expertise, regulatory knowledge (GCP, ICH) and scientific rigor to translate clinical objectives into deliverables that support clinical and commercial decision‑making.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Associate (CRA)
  • Research Nurse / Clinical Trial Coordinator
  • Biomedical Scientist or Pharmacologist

Advancement To:

  • Senior Clinical Scientist
  • Clinical Development Lead / Clinical Program Manager
  • Medical Director / Head of Clinical Development

Lateral Moves:

  • Clinical Project Manager
  • Medical Science Liaison (MSL)
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Design, write and review clinical trial protocols, protocol amendments and associated study documents (e.g., investigator brochures, ICFs) to ensure scientific rigor, operational feasibility and regulatory compliance across phases I–III.
  • Develop clinical development plans (CDPs), study‑level objectives and endpoint definitions aligned with strategic product goals and regulatory expectations.
  • Lead the drafting and critical review of clinical study reports (CSRs), integrated summaries and clinical overviews for regulatory submissions (IND, CTA, NDA/MAA), ensuring accuracy and adherence to ICH E3 and regional guidance.
  • Create and review statistical analysis plans (SAPs) and collaborate with biostatistics to ensure alignment between study design, randomization, sample size calculations and analysis approaches.
  • Oversee safety surveillance for assigned studies: assess adverse events (AEs/SAEs), ensure timely expedited reporting, maintain safety databases and liaise with pharmacovigilance for aggregate safety analyses.
  • Manage end‑to‑end interactions with external partners and CROs, including vendor selection, contracting input, scope of work definition, performance oversight and quality assurance of outsourced activities.
  • Coordinate site selection, feasibility assessments and investigator selection; lead investigator meetings and provide clinical direction to sites to optimize study conduct and data quality.
  • Serve as clinical lead in cross‑functional study teams, translating clinical questions into operational plans and ensuring deliverables are met on schedule and within budget.
  • Ensure studies are conducted in compliance with GCP, ICH guidelines and applicable local regulations; prepare for and respond to audits and inspections by sponsors or regulatory authorities.
  • Perform clinical data review and interpretation, conduct medical monitoring, query resolution and reconciliation with clinical operations and data management to guarantee integrity of safety and efficacy datasets.
  • Develop and implement risk‑based monitoring strategies and medical monitoring plans to proactively identify and mitigate clinical and safety risks.
  • Lead protocol feasibility and informed consent development with patient focus in mind, balancing scientific objectives with ethical, recruitment and retention considerations.
  • Support translational and biomarker strategies: design sampling schemes, interpret PK/PD and biomarker results and integrate translational data with clinical endpoints.
  • Prepare clinical content for regulatory interactions (pre‑IND/briefing packages), respond to health authority queries and participate in regulatory meetings and advisory boards.
  • Provide medical and scientific input into clinical supply and IMP management, including dosing calculations, blinding/unblinding procedures and safety hold recommendations.
  • Mentor and train junior clinical staff, CRAs and cross‑functional colleagues on protocol specifics, safety assessments and clinical endpoints.
  • Contribute clinical expertise to benefit‑risk assessments, interim analyses, DSMB interactions and decisions on study continuation or modification.
  • Lead root cause analyses for protocol deviations, safety signals or data discrepancies and implement corrective and preventive actions (CAPAs) in partnership with quality assurance.
  • Prepare and review manuscripts, conference abstracts, posters and investigator communications to disseminate study results and support scientific communication strategies.
  • Collaborate with commercial and medical affairs teams to align clinical evidence generation with lifecycle management, label claims and post‑marketing study requirements.
  • Drive continuous improvement of clinical processes and SOPs by incorporating lessons learned, industry best practices and regulatory updates into the clinical governance framework.

Secondary Functions

  • Support ad‑hoc clinical data requests, exploratory analyses and medical interpretation for internal stakeholders and cross‑functional teams.
  • Participate in competitive landscape assessments and scientific literature reviews to inform clinical strategy and study design.
  • Contribute to development and maintenance of clinical SOPs, working practices and quality documentation.
  • Support site monitoring visits and remote oversight activities when acting as medical monitor or scientific representative.
  • Assist with investigator training, site initiation visits and regular site communications to ensure protocol adherence and quality data capture.
  • Provide subject matter expertise for internal risk assessments, software tool validations (e.g., eCRF, safety database) and data visualization deliverables.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep knowledge of Good Clinical Practice (GCP), ICH guidelines (E6, E3) and regulatory submission requirements (IND/CTA/NDA/MAA).
  • Protocol design and clinical trial methodology across phases I–III, including adaptive and complex trial designs.
  • Medical writing skills for protocols, CSRs, IBs, regulatory briefing documents and clinical sections of submissions.
  • Safety/Pharmacovigilance competencies: AE/SAE assessment, expedited reporting, aggregate safety reviews and signal detection.
  • Experience collaborating on Statistical Analysis Plans (SAPs) and interpreting statistical outputs; familiarity with biostatistics concepts and sample size determination.
  • Hands‑on experience with clinical data systems: eCRF design, EDC platforms, CTMS and safety databases (e.g., Oracle, MedDRA coding, Argus).
  • Vendor/CRO management: oversight of monitoring, data management, central labs and biomarker partners.
  • Knowledge of PK/PD and biomarker study design and interpretation; familiarity with translational science and assay validation.
  • Regulatory submission preparation and experience responding to regulatory queries and inspections.
  • Experience with investigator engagement, site selection and patient recruitment strategies.

Soft Skills

  • Excellent written and verbal scientific communication tailored to clinicians, regulators and commercial stakeholders.
  • Strong cross‑functional collaboration skills with the ability to lead matrixed teams and influence without direct authority.
  • Critical thinking and problem solving with attention to detail and scientific rigor.
  • Project and time management skills: ability to prioritize competing tasks and deliver high‑quality outputs on schedule.
  • Mentoring and team development; ability to coach junior colleagues and foster a culture of continuous improvement.
  • Adaptability and resilience in a fast‑paced, regulated environment.
  • Ethical judgment and patient‑centric mindset when balancing study objectives with participant safety.
  • Presentation and stakeholder management skills for internal reviews, advisory boards and investigator meetings.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in life sciences, pharmacy, medicine, nursing, pharmacology, biology or a related field.

Preferred Education:

  • Master’s degree, PhD, PharmD or MD in a relevant discipline; advanced clinical training or postgraduate certificates in clinical research are highly desirable.

Relevant Fields of Study:

  • Clinical Research
  • Pharmacology / Pharmaceutics
  • Medicine / Nursing
  • Biomedical Sciences
  • Biostatistics / Epidemiology

Experience Requirements

Typical Experience Range: 3–8 years of clinical research experience, including hands‑on exposure to industry‑sponsored trials.

Preferred: 5+ years of progressive experience in clinical development within pharma/biotech/medical device sectors, with demonstrated experience in protocol development, safety monitoring, regulatory submissions and cross‑functional project leadership.

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