About the Role: We are looking for an Experienced Clinical Study Manager (CSM) to join the Clinical Affairs Team, and ensure compliance with the protocol, overall clinical objectives, and applicable SOPs and regulations. This will be accomplished through planning, implementing, and managing the overall conduct or particular elements of clinical research projects.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities:
- Lead the activities of interdisciplinary Gore team members: plan, execute, and close complex global clinical studies
- Provide study leadership within the project team to foster inclusive teamwork, cooperation and to provide strategic direction on operational study needs
- Responsible to ensure clinical study meets timelines, quality standards and projected cost estimates
- Develop and approve study-specific documents, tools, presentations, and processes
- Oversight of clinical studies to include 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
- Track and report progress of studies to applicable internal stakeholders, to include patient screening, enrollment, data collection, protocol compliance, device accountability, 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
- Minimum of 3 years Sponsor experience in clinical research
- Experience developing clinical trial plans including: protocol development, site monitoring, risk mitigation strategies, trial budgets and site selection/feasibility
- Experience leading and working on cross-functional teams
- Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, EDC, CTMS, eTMF)
- Strong organizational skills, flexibility, and ability to multi-task
- Effective verbal and written communication skills
- Ability to travel up to 30%, including international travel (Travel is primarily U.S. based)
Desired Qualifications:
- Experience in clinical research, scientific research, nursing, medical device industry or pharmaceutical industry
- Minimum of 3 years Project Management experience
*Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
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
