About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
The Clinical Trial Manager is responsible for leadership and execution of clinical studies in support of the direction and goals of the Company. As an integral member of the Clinical Operations team, this position manages all aspects of a clinical study from study concept through site selection, start-up, and close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. In addition, this position develops and assesses SOPs, work instructions and departmental guidance documents, reviews processes for efficiency and compliance, and manages and mentors team members. This position requires the ability to be detailed-oriented, organized, and productive with a keen interest in medical device research. This position reports to the Associate Director of Global Clinical Operations and can be based remote, in the US.
- Develop study protocols and associated documents as the project lead and clinical operations subject matter expert.
- Ability to lead direct reports and provide guidance in completion of required tasks and projects
- Act as the project manager of a cross-functional clinical study team including developing timelines, budgets, resource planning and risks associated with assigned projects.
- Independently manage all phases of a clinical study including essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
- Manage study meetings to ensure completion of established project team goals and objectives.
- Oversee qualification, site initiation, interim and close-out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
- Ability to identify potential risks that may impact the study(ies), e.g., study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution.
- Assess trends in data including adverse events, protocol violations, etc.
- Contribute to clinical reports, data management, data analysis, and publications.
- Participate in assessment of departmental guidance documents/work instructions and procedures, regularly, and development as needed.
- Guide, develop, hire, and motivate direct reports.
- Provide study status updates to the Management team and develop sufficient resolution of identified action items.
- Maintain current knowledge of the applicable US and international clinical regulations and guidance documents.
- Participate in department systems and development initiatives, including related training.
- Support investigator meetings as needed.
- Complete projects and tasks consistent with corporate objectives.
- Adhere to and ensure compliance with Teleflex Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
- Support the Clinical Operations team in general and with various improvement projects.
- Perform other duties as assigned.
Education / Experience Requirements
- Bachelor’s degree, preferably in natural sciences or related field, or related practical experience
- Minimum of 7 years clinical research experience, device experience preferable
- Minimum 2 years Sponsor company research experience
- Minimum 3 years as Clinical Trial Manager (CTM) or similar role
- Minimum 1-year experience managing direct reports or serving in a Team Lead position required. Minimum of 3 years preferred.
- US IDE and OUS MDR experience highly preferred, post-market study experience is desirable.
- Prior clinical study execution experience in a lead capacity
Specialized Skills / Other Requirements
- Must be able to establish and maintain vendor credentials (via RepTrax, Vendormate, etc.) to have the ability to enter and work, as required, in hospitals and other medical facilities, as an essential function of the job. Depending on customer/site requirements, vendor credentials may require the employee to obtain the COVID-19 vaccination, including boosters.
- Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
- Excellent time management skills.
- Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
- Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
- Ability to perform at high levels with limited supervision and effectively partner with team members when necessary.
- Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
- Strong interpersonal and leadership skills, including the ability to function in a team environment
- Ability to communicate and to present information clearly to all levels of staff.
- Proficient in Microsoft Word, Excel, and Access and the ability to quickly learn other software tools and applications.
- Ability to develop strong relationships with investigative sites, internal and external customers.
- Ability to travel up to 30%, as needed.
TRAVEL REQUIRED: Max of 30%
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.