The Sr. Clinical Project Lead reports to the VP, Medical Affairs and shares responsibility for ensuring the safety and efficacy of products worldwide. The Project Lead will assess the clinical data mitigation steps necessary to attain full compliance with the EU IVDR compliance initiative.
Responsibilities: The Sr. Clinical Project Lead will be responsible for representing Medical Affairs (MA) on Core Teams for existing and/or new product initiatives. The CPL represents the interests of the patient and the health care worker/clinician which provides input into product design and quality on behalf of Medical Affairs, which is responsible for ensuring the safety of the product. They will apply basic knowledge of clinical trial design and conduct when interacting with the extended clinical operations team. This person is aware of local/global regulations, complies with policies and procedures, and is familiar with our products, and the product development process. They have experience working with ISO standards and elements of design control. They will review and provide input to product labeling & have a working knowledge of and clear understanding of technical/scientific aspects including product knowledge, clinical knowledge, study design, statistical analysis, etc.
- May provide input into product design on behalf of the Medical Affairs team who are responsible for safety of product. May mentor other associates. Interact with internal stakeholders such as Core team members, Clin OpS, DM and statisticians. May interact with key opinion leaders.
- Must be knowledgeable about key aspects of simple to moderately complex clinical studies to enable accurate inputs into Core Team product development plans.
- Responsible for liaising effectively with the Corporate Clinical Development Group (CCD) in the execution of clinical studies supporting registration of BDB products.
- Provides the project core team leaders with budget and resource needs necessary to conduct clinical studies on behalf of the project.
- Recognizes existing problems, develops recommendations and successfully implements solutions of simple or moderately complex problems.
- Represents Medical Affairs (as part of team) on specific projects/programs. Interacts with clinical investigators and may interact with Key Opinion Leaders.
- Masters degree in a biomedical discipline. Doctorate level degree or other allied health degree/certification in a health-related or life science field is highly desirable.
- 5 years of experience in a regulated industry environment, such as medical device, biotech, or pharmaceutical industries.
- 3 years IVD or medical device experience AND hands-on laboratory experience.
- Excellent written and verbal communication skills, as well as a demonstrated ability to create and organize technical/medical documentation and provide regular updates regarding the status and progress of clinical trials.
- Excellent interpersonal and communication skills, including the ability to perform well in a highly matrixed environment, and to serve as an effective member of a highly functioning multidisciplinary team
- Able to integrate elements in the product development process and leverage support from product team members
- Organized, dynamic, confident, energetic, creative, and open to new experiences and ideas.
- Facilitates the creation of a bottom up /top down, program schedule that gains the commitment of the program team and the Portfolio Decision Team, then monitors and maintains or revises the schedule through the course of the program.
- Demonstrated knowledge of Good Clinical Practices and other Regulations and Guidance's relative to the conduct of clinical trials worldwide
- Demonstrated experience in managing clinical projects, including familiarity with generating timelines, project plans and clinical project deliverables with minimal or no direct supervision.
- Ability to effectively communicate study status, project risks and issues to the project team leaders, clinical study management, and Clinical Research Associates.
- Proven ability to solve problem and mitigate issues.
- Ensures availability of required supplies and/or resources for individual and/or group activities.
- Carries out tasks and activities that are defined in local business/operating plans.
- Strong training and presentation skills
- Intermediate project management knowledge
- Hands-on work habit and down-to-earth personality
- Occasional travel may be required.
- U.S. Citizen/green card holder
- Individuals with previous experience leading cross functional groups are a plus.
- Proven track record in clinical project leadership desired.
- Individuals with previous direct clinical trials experience, preferably within an IVD and medical device industry are highly desired.
- Individuals with experience managing medium to large size clinical studies budgets are highly desired.
- Individuals with a solid knowledge of Good Clinical Practices and other Regulations and Guidance relative to the conduct of clinical trials and sale of laboratory products worldwide are highly desirable.
- Individuals with previous flow cytometry experience or clinical laboratory experience.
- Individuals with experience in Risk Analysis, Human Factor and/or Health Economics evaluations.