Prime Responsibilities Of A Clinical Scientist While Conducting Clinical Trials

The Clinical Scientist has accountability for providing scientific input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. The Clinical Scientist is also Responsible for design and execution in collaboration Medical Monitor for multiple-phase studies. The Clinical Scientist will effectively engage and influence a diverse scientific community of internal and external experts, including collaborations .

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The Clinical Scientist responsibility includes, but is not limited to:

  • Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study
  • Prepare internal and external scientific presentations, research manuscripts and review articles, as required
  • Lead or Contribute as appropriate to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions.
  • Support product validation activities including troubleshooting and analysis of data concluding root cause of failures
  • Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
  • Assist with design, development, implementation, instructions and evaluation of device training programs
  • Integrate data from internal, and external academic, conference and competitor sources
  • Understand and support creation and support of competitor landscape, medical need, regulatory strategy
  • Provide sound scientific and technical advice during product testing phase
  • Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.
  • Support clinical workflow related to patient treatments
  • Escalate product complaints according to the Quality Management System
  • Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP)
  • Assist engineering team by providing input during risk management assessment process which includes product safety and usability from clinical perspective
  • Ensure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents
  • Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP
  • Understands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virology
  • Authors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings
  • Ensures study protocol reflects input from internal and/or external experts/thought leaders
  • Liaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible
  • Provides input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM)
  • Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.)
  • Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.
  • If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter.  Co-ordinates with Medical Monitor/ and other Study Team members and stakeholders.
  • Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (through Medical Monitor/PPL and other stakeholders, as appropriate)
  • Participates in eCRF development and may participate in UAT
  • Reviews the reporting and analysis plan (RAP) and advises on required outputs
  • Participates in data review ongoing through study including interim analyses, in-stream data review, etc.
  • Responsible for ensuring the Go/No-Go criteria have been set for the study
  • Presents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conduct
  • Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries
  • Ensures completion of medical governance (through a physician on the team) and regulatory reporting at the start to ensure overall safety of the study subjects
  • Interpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissions
  • Ensures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriate
  • Understands and anticipates questions from internal and/or external stakeholders regarding data results
  • Working with the stakeholders, clearly communicates results to internal and external stakeholders and regulators
  • Drives content of other clinical documents (e.g. Investigator Brochure); regulatory documents input (e.g. DSURs, BRMP, DCSI, Annual Safety Reports, PBRs, etc.)
  • Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetings
  • Leads completion/filing of key components of clinical modules (NDA/BLA/MAA, AdCom prep, Scientific Advice) for marketing authorization
  • Prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publications
  • Inputs into the organisation of Advisory boards and other scientific engagement activities.
  • Delivers of end-of-study reports and publication/presentation of results
  • Reviews/evaluates external collaborations
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Preferred Qualifications:

  • Basic Life Science degree or equivalent and 5+ years of industry or relevant clinical experience
  • Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
  • Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
  • Broad understanding of the pharmaceutical industry and the clinical development process
  • Clinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publication
  • Matrix management experience; ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Good interpersonal relationship building/maintenance
  • Excellent leadership and influencing skills
  • Experience taking strong cross functional leadership role in clinical development; experience & understanding of clinical development from early stage through to regulatory submission and market support.
  • Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes.  
  • Understands the study, project, and program level and can function successfully across a variety of projects.
  • Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery.
  • Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
  • Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.

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