Clinical Scientist Job Description
Clinical scientist
provides organizational support for Data Monitoring Committees other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
Clinical Scientist Duties & Responsibilities
To write an effective clinical scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Manage clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs
Author, review and approve various study-related documents and plans
Lead and/or assist the study team to design, develop and deliver the clinical study to agreed upon timelines
Assist and/or participate in planning of investigator's meetings
Provide input and coordinate the delivery of clinical trial supplies in collaboration with clinical supply team
Manage escalation of study-related issues
Monitor the status of clinical data collection of assigned clinical studies
Evaluate and extend new concepts by advising colleagues in Product Marketing and Applications on new technical and clinical developments providing innovations which can be developed into new product advantages
Leverage broad expertise in chemistry/radiochemistry/physics/biology or software/system engineering or computer science (depends on area of specialty) to help resolve urgent issues with current products
Play a role in research projects at hospital sites with the possibility of co-authoring publications
Clinical Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Scientist
List any licenses or certifications required by the position: ASCP, MT, CPR, BB, BLS, MLT, IVD, CE, NCA, HEW
Education for Clinical Scientist
Typically a job would require a certain level of education.
Employers hiring for the clinical scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Military, Clinical Lab Sciences, Life Sciences, Medical, Science, Nursing, Biology, Healthcare, Chemistry, Physics
Skills for Clinical Scientist
Desired skills for clinical scientist include:
Statistics
Clinical operations
Drug development process
GCP/ICH
Study design
Disease area
Dose review teams
Establishment and operation of data monitoring committees
Independent response adjudication committees
Compound
Desired experience for clinical scientist includes:
Maintain awareness of panelist issues, product adverse reactions, questionable compliance, etc, and escalate issues to Supervisor to ensure proper testing results
Lead in area of expertise to move projects forward
Certification by the American Society for Clinical Pathology (ASCP) is preferred
Experience in a GLP/GCP laboratory is preferred
Demonstrated competence in all aspects of Clinical Pathology Laboratory work (Hematology, Clinical Chemistry, Urinalysis, Coagulation etc) is required
Experience and knowledge in Immunoassay is required
Clinical Scientist Examples
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Clinical Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of clinical scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical scientist
- Supports Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations
- Guide marketing and sales activities including site visits of strategic customers
- Write white papers, Works-in-Progress brochures, leaflets, slides and video material on new clinical applications for the use of Sales and Marketing
- Technical support during site visits of strategic account customers
- The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan
- Manages the processes required to support external study review committees
- Contributes to multidisciplinary task forces to support continuous improvement
- Prepare or assist with preparation of key documents Investigator Brochures, regulatory submission documents, internal or external presentations
- Work with department managers to prioritize project/study timelines to ensure adequate staffing
- Review publications from the scientific and medical literature for important safety information
Qualifications for clinical scientist
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire
- Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies
- Bachelor’s degree and 12 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- Master’s degree and 10 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- PharmD and 9 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- PhD and 7 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
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Clinical Scientist Job Description
Job Description Example
Our growing company is hiring for a clinical scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical scientist
- Direct experience with generation of MEDDEV 2.7.1 revision 4 compliant CERs
- Detailed knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies
- Experience as a health care professional (e.g., as a nurse, nurse practitioner, physician, physician’s assistant, medical imaging technician, pharmacist)
- Prepares and presents draft study synopsis, protocol, informed consent and clinical documentation associated with IND submissions
- Prepares key documents such as Clinical Study Report, NDA/MAA submission, in coordination with concerned functions (e.g., Medical writing, Regulatory, Biostatistics)
- May provide tactical/scientific mentorship to other clinical scientists
- Trial design, protocol development, and execution (Phase II-IIIb)
- Development assessments of clinical programs to support life-cycle plan and new therapeutic initiatives
- Interact with the FDA, corporate partners and cross-functionally across Genentech/Roche
- Participate in cross-functional teams for the evaluation of new development ideas, franchise medical strategies and business development assessments
Qualifications for clinical scientist
- Bachelor’s degree with 7+ years’
- Understanding scientific process, medical and statistical concepts
- Ability to influence and collaborate internally externally with partners and study-related vendors
- Ability to demonstrate knowledge of and to utilize the principles, theories, practices, methodologies and techniques required of a Clinical Laboratory
- With approvals, may collaborate with and/or direct research projects carried out at universities and laboratories outside the company
- Assess own and others’ research results in order to develop recommendations for future research directions and projects
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Clinical Scientist Job Description
Job Description Example
Our company is looking to fill the role of clinical scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical scientist
- Review clinical data for submissions, drafting protocols and analysis
- The position will involve late stage clinical development with a novel agent for Alzheimer’s Disease currently in Phase III trials, future compounds for other neuroinflammatory indications
- The Clinical Scientist will act as a clinical representative on a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies
- The Clinical Data Scientist (CDS) draws on their extensive clinical and scientific knowledge to ensure relevant data are collected on clinical studies and that the data collected are clinically plausible
- The CDS will perform detailed review of clinical study protocols, ensure the data collection requirements are clear and identify th critical data elements required to be collected in support of the study endpoints
- The CDS will interact with division personnel perform their own independent research to gain a thorough understanding of disease states, procedural details and therapeutic areas
- The CDS will interact with Data Management and members of the Clinical Affairs team to develop high quality and concise CRFs targeted to evaluate the study endpoints
- The CDS will routinely review clinical data to ensure clinical accuracy and proactively identify any trends that may adversely impact data quality
- The CDS will b responsible for leading the development of reports that facilitate medical monitor and/or data monitoring committee review of the safety data perform MedDRA coding of adverse events
- Manages in-stream data flow activities and delivers a quality database in accordance with the Study Data Quality Plan
Qualifications for clinical scientist
- Availability to participate in advisory boards
- Conducts Research & Development (R&D) efforts involving theoretical and experimental study, conception and planning of clinical objectives and coordination and direction of clinical efforts
- Disseminates findings and product implications to management, engineers/scientists, and when appropriate, the scientific and medical community through publications, conferences, reports, and presentations
- Investigates the patent implications of research outcomes and coordinates applications with SJM intellectual property attorneys
- Requires a doctorate with relevant research experience
- Applies technical expertise and/or a thorough specialized knowledge at the forefront of the biomedical profession
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Clinical Scientist Job Description
Job Description Example
Our growing company is looking to fill the role of clinical scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical scientist
- Manages vendor performance against study-specific Service Level Agreements
- Manages data vendor deliverables and performance
- Subject Matter Expert for the Data Quality Community in a specified area(s) of functional expertise
- Trains monitors and site staff on use of data collection tools and query management process
- Timely data integration of eCRF and non-eCRF data to meet database release and freeze milestones
- Expert application of data management and data quality tools to efficiently deliver study objectives
- Challenges the amount of data collected and validation efforts, driving a focus on fit for purpose
- Effective development and use of standards
- Oversight of the deliverables from Clinical Data Scientist Level 8 Professionals
- Management of quality checks and data processing resources at third party suppliers and strategic partners
Qualifications for clinical scientist
- Ability to meet deadlines the ability to converse effectively with all levels of employees, management and customers
- Must be able to work cooperatively and productively with others
- Demonstrated ability to understand and comply with applicable U
- Computer proficiency in basic database entry and graphics presentations
- Ability to manage complex operations and projects under accelerated timelines
- Min 3-5 years experience (maybe as part of the education) in formulation/process development, scale-up and analysis in the field of clinical development
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Clinical Scientist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of clinical scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical scientist
- Participate in strategic collaboration with therapeutic area responsible leads, and clinical research and development colleagues to develop strategic IIS guidance documents
- Partner with Medical Directors in generating research concept sheets for new company sponsored studies and help marshal concept sheets through internal review bodies, external review bodies (e.g., local review committees and co-license partners and Jansen affiliates)
- Work with therapeutic area leaders and operational staff, serve as a liaison between company and clinical investigators
- Support Associate Director, Clinical Project Scientist and therapeutic area leaders with franchise clinical initiatives (program quality, tracking against financial targets, metrics/ timelines)
- Responsible for tracking and managing adverse event data collection across trials (IIS and company sponsored)
- Critically analyze and interpret clinical genetic information
- Generate clear, concise clinical reports
- Work on teams to develop and curate genetic content
- Participate in the development and refinement of tools for analyzing genetic data
- Regularly visit Clinical Science sites in China
Qualifications for clinical scientist
- 3-5 years’ experience executing clinical testing protocols (human clinical testing experience)
- Well-versed with skin bioinstrumentation equipment such as corneometer, cutometer, sebumeter
- Expertise in allergy/immunology/ rheumatology/oncology preferred
- Bachelors degree in Biomedical or Health Care related specialty
- Excellent interpersonal skills and experience of working collaboratively with teams in a matrix environment across functional and geographic boundaries
- Master’s degree in life sciences or medically related field