Precision Life Sciences
Description of Director of Clinical Data Duties
The Director of Clinical Data works with the Regulatory, Engineering, Sales, and Marketing Teams to develop and obtain clinical data related to the Company’s core products and instrumentation, as well as new medical products, devices, and instrumentation. The Director of Clinical Data is responsible for both high-level strategic planning and day-to-day study maintenance, data analysis, etc. related to clinical data collection efforts.
Reports to VP of Regulatory and Engineering.
Responsibilities include the following:
1. Assist in developing cohesive clinical data collection strategies to gather relevant data related to company’s products. Data will be used to support regulatory filings/requirements, support discussions with payors/insurance providers, support marketing efforts, generate scientific publications, etc.
2. Work with the Sales, Marketing, and Education teams to gather feedback on product usage and performance. This feedback will be used to develop clinical data collection plans and study designs/protocols.
3. Implement plans to fulfil the cohesive clinical data collection strategies. This may include: developing clinical study protocols; working with existing physician users to refine/collect/analyze clinical data; working with IRB/Ethics Committees to obtain approval to perform studies; performing literature reviews of existing data; working with CROs to initiate studies, etc.
4. Travel to potential clinical sites to evaluate sites for potential inclusion in clinical studies.
5. Work with sites, physicians, APPs, clinical research staff, company’s Sales representatives, etc. as needed to train personnel on study protocols. Work with personnel to ensure that studies run according to protocol and legal/ethical/IRB requirements.
6. Develop and maintain required documentation in accordance with applicable law, regulations and Company SOP’s.
7. Drafting necessary study proposals and/or IRB/Ethics Committee documents, responding to questions from regulatory authorities, and maintaining required documentation in compliance with applicable laws and regulations.
8. Work with existing and new vendors, physician users, and other third parties to achieve company goals.
9. Assist in performing strategic assessment of company product clinical data and provide recommendations to the management team (i.e., cost; timing; required resources; strategic opportunities). Provide guidance on best practices in each country.
10. Maintain effective communication with all Company team members, including Senior Management and across multi-disciplinary function groups (engineering, compliance, sales & marketing, customer service).
11. Represent the Company with professionalism and integrity at industry conferences, tradeshows, cadaver labs and surgical procedures, educational symposiums, trainings, and workshops.
12. Maintain competence and a high level of expertise in the Company’s current and future product portfolio. Establish credibility within the industry as a thought-leader in the spine and orthopedic medical device fields.
13. Analyze competitive education and training activities. Stay abreast of product development, regulatory approvals and medical advances of industry leaders and competitors within the Company’s medical disciplines.
14. Prioritize and respond to outside inquiries, requests and/or complaints with the appropriate degree of urgency, thoroughness and follow-up.
15. Travel is required to various clinical sites – US based and OSU based.
16. Communicate business, product and ethical matters to the appropriate management team members.
17. Maintain ongoing compliance with applicable laws and regulations in relation to all work-related duties.
18. Identify and implement “best practices” in all work-related activities.
19. Perform other relevant duties, as assigned.
1. Regularly required to work within an office environment, with extended periods of time spent working on a computer.
2. Required to operate office equipment (phone and computer).
3. Occasionally lift and/or move 50+ pounds – medical devices, trays and related equipment.
1. Minimum of 4+ years of medical device clinical data work experience.
2. Experience with clinical studies in the U.S. with additional OUS experience preferred.
3. Experience working as Data Manager or experience managing FDA and/or regulated clinical trials.
4. Ability to comprehend and apply sophisticated logical, critical and scientific thinking on a wide range of intellectually challenging medical concepts.
5. Excellent communication skills, verbal and written.
6. Possess requisite knowledge and expertise in the spine and orthopedic products of the Company. Ability to communicate medical product knowledge, as well as clinical knowledge related to spinal and/or relevant orthopedic anatomy, spinal and relevant orthopedic surgical procedures and techniques.
7. This position requires driving a personal vehicle or a rented vehicle on behalf of the company; therefore, all Company team members must successfully complete a motor vehicle history check, possess, and maintain a current, valid driver’s license in their state of residence.
8. Ability to travel overnight on occasion to attend tradeshows, investor meetings, industry training, and/or other work-related activities.
9. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations.
10. Write reports, business correspondence, and procedure manuals.
11. Ability to solve practical problems. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Analytical and problem-solving skills. Able to define problems, collect data, establish facts, and draw valid conclusions.
12. Ability to work effectively in a team environment.
1. Knowledge of relational databases and experience using multiple clinical data management systems.
2. Knowledge of electronic data capture and data warehouse technologies as applied to clinical trials
3. Ensure adherence to functional budget, and provide updates to manager regarding additional, potential spend or cost savings.
4. Experience with general medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
To apply for this job please visit jobs.crelate.com.