Clinical Study Manager

W. L. Gore & Associates has demonstrated a high-energy commitment to innovation over its 48-year history. Hundreds of products for demanding fabric, medical, electronic and industrial applications have grown out of our commitment to the creation of new, ever-better technologies. That spirit of innovation, challenge, and opportunity combines in a uniquely creative work environment and has contributed to Gore's repeated listing among the "100 Best Companies to Work for in America". Additional information is available about W. L. Gore on our website at www.gore.com



The Medical Products Division of W.L. Gore & Associates Inc. is seeking an experienced individual to provide leadership for a clinical project team responsible for a clinical study. The Clinical Study Manager works directly with the Clinical Team Leader. Specific responsibilities for this position include:

1)Leading and interfacing with a multi-faceted clinical project team (Clinical Team Leader, biostatistics, data management, clinical monitors and regulatory associates) to achieve successful clinical studies within appropriate timeframes.
2)Initiating, monitoring, and managing clinical trials for medical devices, ensuring compliance with the CFR, GCP and all internal SOPs and guidelines.
3)Serving as a liaison between company and contract research organizations, core laboratories, field sites, investigators, study coordinators, physicians and staff members for specific project or study. As such, communicating issues and opportunities to Clinical Team Leader and clinical leadership. Coordinate interaction with core laboratories, CECs, DSMBs.
4)Communicating project progress, challenges, and opportunities on a regular basis to Clinical Leadership both verbally and written.
5)Participating in pre-study and site initiation planning, including investigator meetings and clinical site recruitment. Participating in selection of core laboratories and CROs and formation of study committees.
6)Writing and developing clinical protocols, data and tracking forms, informed consent documents, operating procedures, and other documents necessary for a well-managed clinical study in conjunction with Clinical Team Leader.
7)Monitoring clinical and/or laboratory data to ensure accuracy, thoroughness and regulatory compliance of clinical documentation, and ensuring resolution of data queries.
8)Monitoring all safety issues and continuous site evaluation and working with Clinical Team Leader to resolve.
9)Overseeing delivery, shipment, inventory, and accountability of investigational products and equipment required to conduct clinical investigations.
10)In conjunction with Clinical Team Leader, writing annual and final clinical study reports and clinical sections of regulatory filings.

Qualifications
College degree required, preferably in nursing, allied health, bioengineering, or life sciences.
Proficient in project management and clinical research in a lead position in the IDE / medical device arena with 5 to 8 years experience.
PMA experience desirable.
Knowledge of FDA regulations and Good Clinical Practices essential; familiarity with Quality System Regulations necessary.
Outstanding organizational skills, flexibility and attention to detail required.
Excellent verbal and written communication skills required.
Willingness to travel 25% to 50%.



W. L. Gore & Associates, Inc. is an equal opportunity employer.
For further information regarding Gore, visit our website at www.gore.com