Expected Travel: Up to 50%
Requisition ID: 11722
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Vascular Access – Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary** REMOTE ROLE **
The Clinical Trials 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 Evidence Generation 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, reviews processes for efficiency and compliance, and manages and mentors team members.
Principal Responsibilities• Customer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers.
• Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus.
• Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.
• Develop study protocols and associated documents as the project lead and clinical evidence generation subject matter expert.
• Lead direct reports and provide guidance in the completion of required tasks and projects
• Act as the project manager of a cross-functional clinical study team including developing timelines, budgets, resources 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.
• Identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions.
• Assess trends in data including adverse events, protocol violations, etc.
• Contribute to clinical reports, data management, data analysis, and publications.
• Develop and assess SOPs annually.
• Provide study status updates to the Management team and develop sufficient resolution of identified action items.
• Monitor emerging trends to help integrate new requirements into department procedures.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives, including related training.
• Support investigator meetings as needed.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Evidence Generation team in general and with various improvement projects.
• Perform other duties as assigned.
• Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.
• Minimum eight years of clinical research experience, medical device experience preferable.
• Minimum two years of Sponsor company research experience.
• Minimum two years of experience managing direct reports or serving in a Team Lead position required. A minimum of three years is preferred.
• US IDE and OUS experience highly preferred, post-market study experience is desirable.
• Knowledge of cardiovascular disease state or willingness to undergo rigorous and fast learning independently.
• Ability to be detail-oriented, organized, and productive with a keen interest in medical device research and urology.
• 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 communicate and present information clearly to all levels of staff.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• 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, and internal and external customers.
The pay range for this position at commencement of employment is expected to be between $140,000- $152,100 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
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: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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