Waltham - Waltham, MA
Up to 30%
By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
The Clinical Research Manager (CRM) will have operational responsibility for the execution of the company's clinical trials and clinic-based studies. The main responsibility will be to work closely with senior management, particularly the Sr. Director Clinical Affairs, and the Chief Science Officer to ensure that the appropriate Principal Investigators and clinical trial sites are identified, protocols, informed consent forms, case report forms and any other required documentation is prepared and submitted in timely fashion to IRBs agreed upon by Exosome Diagnostics for our external clinical trials. The CRM will manage the timely enrollment of patients, reporting to senior management on a regular basis as to the statusof the clinical investigations. The CRM will be accountable for delivering all relevant clinical data required by the protocol to the biostatistician assigned to the project.
- Manage all internal and external resources and activities relating to the delivery of clinical trial results and support the company's product registration objectives with FDA and other international regulatory bodies.
- Build and maintain excellent working relationships with primary clinical trial sites and insure that the requirements of the company are met and maintained.
- Ensure that all study activity is in accordance with Exosome DX's standard operating procedures.
- Manage the execution of all aspects of study logistics (e.g., collection kit shipments, sample retrieval and storage, assay and extraction kit shipments) for clinical trials as assigned.
- Arrange transportation and shipping of clinical supplies and samples via company-approved couriers.
- Provide in-servicing and/or educating of hospital, office and ancillary service personnel with regards to all appropriate aspects of the clinical trial protocol.
- Manage completion of all study related documentation (e.g., CRFs) according to IRB approved protocol and Standard Operating Procedures.
- Organize and attend Investigator meetings and training sessions as needed.
- Facilitate communication between, R&D, Senior Management and investigational sites by arranging meetings, drafting and sending routine correspondence and by presenting regular updates to senior staff.
- Participate in the development of clinical strategy and trial design by conducting meetings with the appropriate individuals to obtain feedback/direction.
- Provide accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, etc.
- Provide writing and technical support for SOPs, protocols, and Statements of Work as needed.
- Participate in the review and update of existing procedures and develop new procedures as needed.
- Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
- Performs additional duties as assigned.
Education and Experience:
- Bachelor's BS or equivalent experience in a scientific or medical discipline; master's degree preferred.
- 7+ years of experience in diagnostics, biotech, life sciences or medically related field preferred.
- 5+ years of clinical research experience working on industry-sponsored or industry-partnered clinical trials and investigations in a biotech, pharmaceutical or CRO company. Experience in managing clinical trials and clinical investigations at academic institutions may also be considered.
- Experience in managing clinical trials and clinical investigations for registration of diagnostic products with FDA and other international regulatory bodies is highly desirable.
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors).
- Previous management or project management experience with demonstrated leadership ability.
- Previous budget and contract negotiation experience
- Knowledge, Skills, and Abilities:
- Excellent communication skills, both written and oral, and completely familiar with the vernacular of the clinical trials and regulatory approval process
- Ability to successfully negotiate clinical trial partnerships with representatives of institutional IRBs and clinical trial site representatives on matters related to clinical protocol, consent forms, sample costs, staff charges, and institutional overhead
- Detail oriented and highly organized in documentation of non-disclosure agreements, material transfer agreements, and clinical protocols.
- Has a working understanding and excellent record of interfacing with biostatisticians in both design and analysis of clinical data.
- Shows high degree of persistence and drive to accomplish goals in a timely manner.
- An ability to build relationships and influence medical professionals in both academic and community-based practice settings.
- Ability to determine the resources and support to meet project goals and timelines.
- Knowledge of FDA and international regulatory requirements.
- Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs.
- Excellent time management skills (timelines, schedules, task prioritization).
- Willing and able to travel up to 30% of time.