Clinical Affairs Job Description
Clinical affairs
provides guidance and technical expertise to assure that Clinical Affairs activities are conducted in compliance with applicable regulations, including, but not limited to ISO 14155, FDA regulations, and Good Clinical Practice (GCP) standards.
Clinical Affairs Duties & Responsibilities
To write an effective clinical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Activities for Pathology Imaging Systems projects
Taking radiographs, setting up and breaking down dental material for needed procedures, taking impressions and bite registrations, fabricating and cementing temporary crowns, retracting and suctioning during tooth preparations and operative procedures for fixed prosthodontic and periodontic procedures, all while ensuring optimal patient comfort
Sterilize instruments for re-circulation including suction heads and treatment bay cuspidor
Prepare patients for procedures which include delivering patient personal oral hygiene instruction
Assist with reviewing and inputting treatment plans, ensure that consent forms are completed, organize lab cases by monitoring completion dates
Collect patient data by reviewing medical history, taking blood pressure and pulse, charting clinical findings as directed
Practice and adhere to infection control guidelines and OSHA and HIPAA regulations during and after such said procedures and maintain an inventory of supplies to avoid shortages and restock cabinets when indicated
Demonstrate practice management skills by working as a back-up resource for patient coordinator during an absence
Coordinate all travel arrangements related to the SVPHS and CTS executive team while working closely with the Accounting department in the Office of the SVPHS to ensure best practices are followed for timely reimbursement
Ensure timely and accurate information flow to and from the CTS Executive Team’s office and the Office of the SVPHS, via all forms (correspondence, forums, speeches, conferences, retreats)
Clinical Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Affairs
List any licenses or certifications required by the position: PMP, CCRA, ACRP, M.D, RAC, GCP, CCRP
Education for Clinical Affairs
Typically a job would require a certain level of education.
Employers hiring for the clinical affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Medical, Education, Technical, Biomedical Sciences, Life Sciences, Science, Nursing, Engineering, Biological Science, Health
Skills for Clinical Affairs
Desired skills for clinical affairs include:
Good Clinical Practices
Biostatistics and Good Clinical Practice
GCP
Pathology
Clinical study design
Oncology
FDA regulations
Current industry practices related to the conduct of clinical trials
Medical terminology
Good Clinical Practice
Desired experience for clinical affairs includes:
Work with the faculty research mentors as needed to support the program and the degree candidate students
Initiates clinical trials and ensures sites’ readiness
Responsible for the site monitoring plan
Prepares data summaries, reports and presentations for design reviews
Being the primary contact for conducting and execution of product-related trainings for countries (RCO) basing on Needs Assessment
Contribution to the Train-the-Trainer (TTT)program to ensure continuing education of Sales Force, including Helpdesk functions, on products and related topics
Clinical Affairs Examples
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Clinical Affairs Job Description
Job Description Example
Our company is looking for a clinical affairs. 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 affairs
- Development of training material, show cases in collaboration with external experts, dentists, labs if applicable
- Drafting target group specific training content basing on relevant available information, claims, DFU, scientific literature
- Proper documentation of campaigns, T&E activities, and contribution to required reports
- Collaboration with external speakers, KOL
- Capturing Voice of Customer
- Customer support upon request (Technical Advise)
- Evaluation of technical/ clinical complaints upon request
- Support of 3rd level helpdesk (global) upon request
- Compliance with company policy and procedures
- Complaint reporting in accordance to complaint handling process
Qualifications for clinical affairs
- Active support of product development, core project member, and handlings-tests (upon request by R&D/ Marketing)
- Experience conducting approval and surveillance studies in support of PMA and 510(k) is preferred
- Solid understanding of scientific/clinical research is essential
- Advanced user of Microsoft Office applications such as MS Word, Excel, Project, and PowerPoint is preferred
- Must have experience in the clinical development of Class II or Class III medical devices from feasibility through commercialization in the US Working knowledge of statistical methodology and application of statistics in scientific and medical /clinical research
- Effective presentation skills are necessary
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Clinical Affairs Job Description
Job Description Example
Our growing company is looking for a clinical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical affairs
- Direct the design
- Coordinate functional areas involved in clinical operations to solve problems
- Monitor training effectiveness by assessing trends in audit observations and drive continuous improvement initiatives by developing new training activities
- Negotiate contracts with investigators
- Provide compliance guidance on the conduct of clinical research division-wide
- Helps develop and maintain a deep understanding of our global Regional Country Organization (RCO) CA needs to achieve business objectives
- Manages the successful implementation of operational, process and new and improved programs and projects on time, within budget and within scope
- Applies best practices, strategically utilizing the team’s talents and skills to add value to the business, through successfully managing the completion and execution of projects and driving learning and improvements
- Manages the collective relationships between and among the stakeholders and team members, instilling confidence with the organization through consistent results
- Oversees all management aspects of projects, setting deadlines, assigning responsibilities, and monitoring progress
Qualifications for clinical affairs
- In-depth knowledge of local evidence needs and local laws and regulations
- Understanding of the clinical laboratory, assay / instrument principals involving in-vitro diagnostic product design and usage
- Ability to accurately evaluate and assess complex processes
- Strong computer skills including Microsoft Office Suite with a specific focus on Power Point
- Exposure to clinical research is preferred
- Bachelor's degree in relevant scientific discipline, higher degree desirable
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Clinical Affairs Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical affairs
- Demonstrated in-depth knowledge of medical device development, clinical trial management of Class II and III devices, and understands the application of appropriate FDA, GCP, and ISO Standards to meet regulatory and compliance requirements
- Performs risk management to minimize project risks, while creating and maintaining project documentation
- Frequent international travel to attend quarterly Potential Available Market (PAM) meetings and interface with Switzerland-based staff
- Integrate scientific and clinical knowledge to successfully execute clinical studies in compliance with investigational plans and all applicable regulations, and in line with business goals and objectives
- Monitor and/or interpret results of clinical investigations in preparation for device application and to establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of therapy or medical device product
- Leads and directs pre-market clinical affairs activities to ensure completion of all cross functional activities for product development activities
- Develop and prepare key evaluation documents in conjunction with other team members
- Manage US Safety CRAs and Sr
- Represents Safety during inspections of the company
- Develop significant scientific relationships with clinical investigators and research staff
Qualifications for clinical affairs
- Bachelor's Degree in a related field (e.g., biological, medical, public health, regulatory science, physical sciences, engineering) is required
- Minimum of 5 years of experience in medical device industry, inclusive of 3 years of experience managing clinical trials in medical device industry for Endoscopy or related business, 2 years managing department objectives, including personnel and cost centers/budgets, and 2 years managing department objectives, including personnel and cost centers/budgets is required
- Possess a University Degree (Bachelor or Master) in a relevant technical, clinical or biomedical field
- Regulatory knowledge in a number of therapeutic areas, orphan drug experience a plus
- 5+ years in an upstream marketing role or product marketing role
- Bilingual abilities a plus (English and French)
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Clinical Affairs Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical affairs. 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 affairs
- Adhere to corporate and healthcare compliance guidance in all activities, including those related to clinical trials, and scientific interactions with internal and external groups
- Represent the company and sponsor during exchanges with clinical trial sites
- Establish and maintain long-term collaborative relationships with clinical trial investigators and research staff
- Assist with clinical trial awareness and study execution
- Assist primary safety officer in product investigation meetings, HHAs, and NCRs as needed
- Demonstrated ability to supervise, lead and develop technical staff members
- Ability to build and maintain partnerships with internal customers and stakeholders
- Demonstrated ability to plan, implement and manage multiple projects in a fast-paced environment
- Demonstrated ability to develop, influence and manage relationships with medical and scientific investigators, CECs, DSMBs, CROs and Core Laboratories
- Strong analytic skills for strategic review and assessment of the medical literature, clinical and statistical data interpretation and scientific study proposals and oversee data management activities
Qualifications for clinical affairs
- Understands the significant role of Clinical Affairs, on a global level, to facilitate adoption and use of a company’s medical device products, and solutions to increase clinician’s competency, effectiveness and efficiency
- Ability to lead people effectively
- Strong influencer and persuasion skills
- Ability to motivate, enthuse, build respect and rapport
- Ability to build strategic relationships with peers, KOL’s and other business stakeholders
- Internet and Email applications
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Clinical Affairs Job Description
Job Description Example
Our innovative and growing company is hiring for a clinical affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical affairs
- Monitors the progress of the project and updates clinical project leader on an ongoing basis
- Prepares, oversees, and reviews the preparation of clinical documents, , Protocols, Investigator Brochure, Annual Report updates, Case Report Forms and Clinical Study Reports
- Lead clinical risk assessment for adverse events, participate in decision on field corrective actions
- Develop, implement and collaborate on training for company operating procedures, GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements, process improvement training and proctoring new employees on trial and study related activities
- Collaborates with Lead CRAs to collect feedback and information related to monitoring visit reports, site report cards and dashboards for ongoing management of site issues
- Management and oversight of the Clinical Project Associate team’s activities, ensuring compliance with applicable regulations and SCRI SOPs
- Manage the performance of direct report personnel, including role expectations and performance reviews
- Ensure adequate support, trouble shoot performance issues, and identify and develop training opportunities for department and individuals
- Supervise, educate, direct and support the Clinical Project Associate Team
- Develop and define career development pathways for the Clinical Project Associate Team to ensure stabilization and minimization of staff turnover
Qualifications for clinical affairs
- Familiarity with dental CAD/CAM technologies
- Must be able to set priorities adapt to changing priorities
- MD, DO or PhD from an accredited institution in a Medical/Scientific discipline
- MD or DO with eight plus (8+) years OR PhD with ten plus (10+) years industry experience in US medical affairs, understanding of the US clinical practice environment and clinical drug development
- Clear record of successfully planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, regulatory submissions and a demonstrated ability to function at a program level
- Comprehensive and authoritative knowledge in the therapeutic area