CLINICAL RESEARCH MANAGER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS
Updated: Nov 22, 2024 - The Clinical Research Manager specializes in orchestrating clinical investigations for hearing instruments and related devices. This role requires adeptness in designing, preparing, and managing documentation compliant with stringent regulatory standards. Expertise extends to obtaining necessary approvals from ethical committees and competent authorities, ensuring all aspects of clinical trials are conducted efficiently and ethically.
Essential Hard and Soft Skills for a Standout Clinical Research Manager Resume
- Clinical Trial Design
- Regulatory Compliance
- Data Analysis
- Protocol Development
- Budget Management
- Project Management Software
- Statistical Analysis
- Medical Writing
- Pharmacovigilance
- Ethics Submission and Approval Processes
- Leadership
- Communication
- Problem-Solving
- Attention to Detail
- Adaptability
- Interpersonal Skills
- Time Management
- Team Collaboration
- Ethical Judgment
- Conflict Resolution
Summary of Clinical Research Manager Knowledge and Qualifications on Resume
1. BS in Biology with 5 years of Experience
- Pervious TA experience in ophthalmology
- Clinical research experience, as CRA including relevant on-site monitoring experience.
- Able to work in a fast paced environment with changing priorities
- Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Ability to work independently as well as in a team matrix organization and multiple projects
- Strong leadership and mentoring capability with proven track record
- Good communication skills in English (written and spoken)
- Ability and willingness to travel (domestic and overseas)
2. BS in Biochemistry with 4 years of Experience
- Experience in the field of clinical research
- Advanced knowledge of GCP guideline and all applicable clinical research requirements. Awareness of all countries regulation as applicable for territory coverage
- Passing internal or external audits with no critical findings and less than 8 major findings in the last 2 years
- Successful track record of coaching & mentoring for at least 3 different team members
- EOY performance review of at least exceeding expectation
- University degree with life sciences background
- Line management certificate or diploma
- Leadership and good sense of teamwork
- Excellent analytical, organizational and decision-making skills, people management
- Ability to work under pressure and to keep tight deadlines
- Strong communication and influencing abilities
- Ability to manage and resolve conflicts between subordinate
3. BS in Biomedical Science with 6 years of Experience
- Experience in working with complex clinical trials from a site, sponsor or CRO perspective
- Understanding of FDA regulations, GCP, study start-up, clinical trial agreements, trial budgets, IRB submission and pharma operations
- Collaborative team player
- Exceptional customer service skills and strong interpersonal and problem solving skills
- Proven track record of setting and achieving high personal standards of performance
- Highly organized and systematic, superb attention to detail, and ability to complete tasks with a high degree of accuracy and an eye towards process improvement
- Flexible and adaptable, ability to work independently in a fast-paced environment
- Experience with rapid site activation
4. BS in Clinical Research with 7 years of Experience
- Experience with designing and preparing documentation for clinical investigations of hearing instruments or similar
- Experience with conducting clinical investigations
- Good working knowledge of relevant regulations, e.g., ISO14155
- Good communication skills, and speak and write English proficiently
- Clinical experience or a deep understanding of hearing aids, bone anchored hearing systems, or cochlear implants
- Experience from obtaining approval from ethical committee and competent authorities on clinical trials
- Interest in medical imagery.
- Solid project management or people management experience.
- In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules.
- Effective written and verbal communication skills including good command of the English language.
5. BS in Nursing with 15 years of Experience
- Good knowledge of clinical trial methodology
- Up-to-date knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOP's
- Knowledge of drug development process
- Computer literacy and IT skills, including spreadsheets
- Project and budget management skills as well as analytical perspectives
- Customer management skills
- Proven experience in conducting clinical trials monitoring and trial management in accordance with ICH-GCP
- CRA people management experience
- Related experiences in pharma industry or CRO
- Global MNC / Matrix Organization experience is a plus
6. BS in Pharmacy with 8 years of Experience
- Strong CRA background, with onsite monitoring experience.
- Proficiency with medical terminology and business English
- Working knowledge of Local Regulations
- A demonstrated working knowledge of ICH/GCP Guidelines
- Excellent record-keeping skills and attention to detail
- Ability to build and nurture team relationships.
- Experience with client facing role/activities.
- Detail-oriented, self-driven, with good organization and good interpersonal communication skills
- Must be able to multi-task, learn quickly and work efficiently
- Experience as a research coordinator
7. BS in Public Health with 3 years of Experience
- Masters in pharmacy, life or medical science specialty or equivalent
- Sound knowledge of ICH-GCP and clinical research
- Working at a Lead CRA level and have demonstrated consistently meeting high standards
- Fluent in English and either fluent in French or German, spoken and written
- Sound working knowledge of MS office applications (Word, Excel, PowerPoint)
- Flexibility & willingness to travel up to 20% to resource limited countries
- Team player with good communication skills
- Precise working style and interest in tropical diseases
- Ability to work independently
- Experience in TB and/or Eastern European countries
8. BS in Medical Technology with 5 years of Experience
- Experience in the clinical research space, preferably in medical device studies
- Advanced degree in engineering, life sciences, or related medical/scientific field
- Proven leadership, communication skills and technical skills needed to plan and execute clinical trials
- Experience managing medical device studies under IRB
- Ability to travel 30% domestically and internationally
- Experience designing research protocols, developing study documents and maintaining a trial master file
- Experience interpreting and evaluating study results and writing detailed study reports
- Knowledge of data analysis and statistical methods is a plus
- Strong experience and understanding of clinical research and clinical trial design, data analysis, statistics, and methods.
- Good knowledge of GCP aspects and FDA guidelines.