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Senior Clinical Trial Manager
Location
Pennsylvania
Posted
62 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Trial Manager
ICON plc
• The Senior LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. • The Senior LTM will serve as the country-level single point of contact on the study for internal partners. • They are site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles. • Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution. • Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams. • Principal Local Operations Manager: trial aligned member of CFTT for USA-level accountability, serves as “quarterback” for Local Operations Managers and representing a single voice to the global team. • The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors. • Execution of local milestones from feasibility through study close out. • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM). • Inspection Readiness and AQR at the country level. • Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary. • Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence. • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables. • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation that may be required by leadership. • Autonomy with execution of local trial management services. • Depth of knowledge with local trial management services.
Job Requirements
- BA/BS degree.
- Degree in a health or science related field.
- 3 - 5+ years of trial end to end management experience.
- Start-up & Database Locks/Cleaning experience preferred.
- Solid Tumor and/or Hematology Oncology experience required.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stay away from home according to business needs.
- Proficient in speaking and writing the country language and English.
- Good written and oral communication skills as appropriate.
- Must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we’ve been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what’s possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: - Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. - Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. - Acting as a clinical interface between the medical community and the business. - Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. - Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. - Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. - Supporting EP Sales Representatives in the following areas: - Collaborating with sales personnel; - Facilitating regional training seminars; - Participating in clinical studies/data collection; - Troubleshooting; and, - Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. - Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. - Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. - Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. - Participating in occasional travel for in-person instruction and live procedure coverage. 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