Clinical Research Manager
Category: Clinical Research Manager
Our client is in need of a Clinical Research Manager who will be responsible for providing clinical guidance, strategy, and support for pre- and post-market clinical research and surveillance.
This position will direct project activities associated with monitoring functions of clinical research studies while furthering the Company’s understanding of the medical device development process, Good Clinical Practices, and relevant regulations.
They will manage the Company’s contracted regulatory and clinical support resources including CROs and consultants and monitor clinical study site activities to ensure subject enrollment and the integrity of clinical data is in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
He/she will work within a team environment under Quality Management System (QMS) objectives and will provide mentorship and training to other members of the organization to support clinical research efforts.
The CRM will interact with the Clinical and Scientific advisory boards to solicit guidance and encourage their input relative to clinical strategy, protocols and market intelligence.
• Manage the development of clinical protocols, including development of informed consent forms, data forms, monitoring plans and all related study documents.
• Assure compliance with all applicable clinical policies, guidances and regulations.
• Coordinate clinical operations including design and initiation of clinical trials to optimize tactical and clinical value through global site selection and data portability in both trials and pre-clinical research, as well as post-market research.
• Assist in the preparation of Investigational Device Exemption (IDE), Internal Review Board (IRB) and Ethics Committee submissions including protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required.
• Achieve study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
• Assist in site selection and pre-study activities to identify and evaluate potential investigators. Complete site evaluation for qualification/selection of investigators/sites.
• Manage clinical trial initiation, monitoring and close-out activities while adhering to all applicable regulatory requirements.
• Manage and participate in the preparation, coordination and implementation of Clinical Advisory Board and investigator meetings.
• Continue to increase knowledge of medical device development process, Good Clinical Practices, and any applicable regulatory requirements.
• Participate in quality improvement efforts to increase overall operational efficiency, e.g. assist in departmental procedure development and training efforts.
• Interface with the management team to ensure that clinical activities are aligned with overall strategic goals.
• Provide up-to-date evidence-based clinical intelligence on the Company’s technology and clinical applications from peer-reviewed publications.
• Assist Marketing and/or other applicable departments with clinical input in preparation for publications, corporate presentation, professional education, symposia, trade/medical shows, and similar outreach programs.
• Collect, review and track regulatory documents when required.
• Prepare regular progress reports on assigned projects.
• Travel 20% to 50% of time.
Qualifications and Skills:
• Bachelor’s degree or equivalent required (BS/BA or RN).
• Minimum of 10 years clinical research experience with 3 years project management.
• Knowledge of FDA guidelines for clinical trials and experience with IDE or IND submissions.
• Excellent verbal and written communication skills.
• Excellent organizational skills.
• Medical device experience and/or urology experience preferred
Location Ann Arbor , MI
Minimum Experience (yrs): 10+
Required Education: Master
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