DEKA has a new and exciting opportunity for a Clinical Research Manager to manage assigned clinical studies and drive processes to meet project milestones and deliverables. This role will maintain compliance with applicable laws, regulations, standards, company standard operating procedures, and corporate policies governing clinical studies. This role requires CRO management and direct study execution responsibilities including study strategy and design, protocol development, CRF design, creation of ICFs, Investigator Brochures, monitoring, implementation of clinical plans, clinical study management, and analysis of clinical data, and clinical reports. This position requires active involvement to maintain schedules, resolve challenges and conflicts, and entails frequent interaction with DEKA clients and functional peer groups at various management levels. There may also be line management responsibilities for Clinical Research Associates.How you will contribute:
Needs for success:
- Manage studies for DEKA-developed medical devices, working with CROs, principle investigators, medical director, medical support personnel, statisticians, data management, study monitors, CRAs, etc.
- Primary interface and project clinical liaison between DEKA DEKA customers and CRO's in areas pertaining to clinical study design and conduct.
- Provide leadership in the delivery of services to clients, ensure CRO's, service and contract organizations fulfilltheir responsibilities in accordance with clinical research program policies, procedures and SOPs.
- Ensure studies are conducted in compliance with U.S. laws and regulations in CFR Title 21, the international ICH E6 Good Clinical Practices and country specific regulatory requirements.
- Contribute to the design of clinical trials. Oversee, create, and/or assist in developing the required clinical documents such as Informed Consent Forms, Case Report Forms, Adverse Event Forms, etc.
- Assist Regulatory Affairs in preparing and submitting study request documentation to various regulatory agencies (FDA, CA etc.)
- Oversight of clinical sites, including clinical site contracts, principal investigators contracts, completed financial disclosure forms, site start-up (e.g., completion of regulatory documents and IRB/IEC approvals), subject recruitment, data entry/transcription, timely completion of logs (e.g., Screening/Enrollment and AE logs).
- Preparation of clinical study report
- Bachelor's degree or equivalent in Engineering, Health Sciences, or Nursing.
- Minimum of five years of experience managing medical device clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning, and management.
- Highly developed leadership skills to manage CROs, build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met.
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and execution.
- Thorough understanding of CFR Title 21, International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reporting.
- Proactive and critical evaluation of all aspects of clinical development to ensure accountability at multiple levels.
- Ability to work with a continued focus on quality, efficiency and ongoing improvement.
- Effective written and verbal communication skills necessary to meet the needs of various audiences.
- Strong problem solving, decision making, prioritization, and organizational skills.
- Continuing education is mandatory to remain current on evolving regulatory requirements and medical practices
- Experience with renal/hemodialysis patients and studies a plus
- Some travel, less than 10%
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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