Clinical Study Manager
Advanced Clinical is looking for a Clinical Study Manager to join a fast growing company in North LA, California. This Clinical Study Manager will be responsible for building a clinical trial plan and overseeing that the trial is conducted in compliance with GCP, FDA, and ICH guidelines. They will also be expected to have a broad and extensive knowledge of clinical trial activities and will be expected to independently solve a broad range of problems. This Clinical Study Manager plays a key role in managing, training, and/or evaluating the clinical research project team members. If you have the skills and drive, contact Nicole today NSwiecicki@advancedclinical.com
- Developing and implementing clinical protocols from research concept according to the Investigative Product Development Plan.
- Assist with IDE, 510(k) and PMA submissions the FDA.
- Planning and conducting the Site Qualification and Site Selection process in conjunction with other members of the clinical affairs team.
- Reviewing and approving of Investigative Sites in conjunction with other members of clinical affairs and senior management team.
- Assisting in development negotiation execution and management of the study budget, within the approved budgets and timelines including billing and invoicing.
- Coordinating activities and clinical proposals of multiple outside investigators.
- Developing, negotiating and maintenance, of contracts with Investigative Sites and vendors.
- Set up cadaver labs for investigator and staff training.
- Responsibilities for effective communication within the Clinical Project Team and with functional management.
- Developing Monitoring Plans and CRF Guidelines.
- Overseeing timely reports of Serious Adverse Events and Serious Adverse
- Device Events to the IRB/IEC and FDA, follow-up and resolutions of these events.
- Reviewing site visit reports and responsible for checking that reports arecompleted, and distributed in accordance with the applicable studies to the senior management, clinical affairs team, R & D and Manufacturing departments of the company.
- Developing and maintaining appropriate study specific and department specific SOPs.
- Participating in skill improvement seminars on regular bases.
- Able to react to change productively and to perform other essential tasks assigned.
- May travel up to 30%.
5+ years of CRA experience plus at least two years of study management under minimal supervision in the medical device industry.
BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline.