About the Role: We are looking for an Experienced Clinical Study Manager (CSM) to join our team. In this role, the CSM is focused on designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CSM is to ensure compliance with the protocol and overall clinical objectives, as well as applicable SOPs and regulations.

This position will be located in Flagstaff, Arizona, Phoenix, Arizona, Elkton, Maryland or Newark, Delaware with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Responsibilities:

Coordinate the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies
Develop and approve study-specific documents, tools, presentations and processes
Overall oversight of clinical studies including activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of DSMB / CEC / Steering Committees, and participation in site visits as necessary
Assist with the management of medical device distribution, receipt, use and return
Routinely review data / CRFs to ensure data integrity, accuracy and protocol compliance
Track and report progress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation and reporting
Develop Study Reports and provide clinical portions for Regulatory submissions
Manage non-compliance for resolution and prevention
Participate in process improvement efforts
Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position

Required Qualifications:

Bachelor’s degree in a science or health-related field OR a minimum of 5 years clinical research experience
3 years Sponsor experience in clinical research, scientific research, medical device industry or pharmaceutical industry
Experience working on cross-functional teams
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
Strong organizational skills, flexibility, and ability to multi-task
Strong verbal and written communication skills
Ability to travel up to 30%, including international travel (travel is primarily U.S. based)

Desired Qualifications:

Have a strategic planning skillset and drive the project forward
Previous Clinical Study Management experience with strong program management skills
Ability to lead others and drive stakeholder management with demonstrated ability to be highly organized

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being.

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world.

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

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W.L. Gore & Associates

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Senior Clinical Study Manager