Senior Clinical Study Manager
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
Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s hybrid working policies, from the country in which they are employed.
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. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
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. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
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 will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
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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