Clinical Team Manager
Location : United Kingdom
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
What do you need to have? Education:
- Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
- 8 years of relevant experience
- Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
- Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
- Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal and external partners.
- Solid understanding of country local regulations, ICH-GCP guidelines and company written standards.
- Flexible and resilient with ability to evolve in changing and challenging environment.
- Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.
Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Working fully embedded within one of our global pharmaceutical clients, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation. As a Clinical Team Manager you will be dedicated to one of our global pharmaceutical clients who aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, preventing and treating disease. The Clinical Team Manager is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CTM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Phase I-IV clinical studies within and across therapeutic areas. The CTM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities.
- May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input
- Assess appropriateness of study for local environment
- Conducts country/site feasibility.
- Leads selection of sites within country; accountable for site performance.
- Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning.
- Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management.
- Accountable to manage recruitment into clinical studies in accordance to relevant country commitments including contingency planning.
- Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department.
- Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials.
- Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally.
- Responsible for submitting or assisting with (in accordance with local regulations and our client’s standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals.
- Arranges accurate translations of key study documentation into local language as required.
- Provides support / develops and negotiates Clinical Trial Agreements (depending on our client’s local practices) with the investigational sites, ensuring legal input where required.
- Ensures necessary supplies are available at sites and manages local supply inventory.
- Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites’ progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed.
- Build close working relationships with key partners including local medical staff.
- Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training.
- Ensures the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities
- May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports.
- Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy.
- Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.
- Ensures robust communication with sites, e.g. timely communication of protocol amendments.
- Reviews and approves Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.
- Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting).
- Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and written standards.
- Reviews, ensures completeness and maintains accuracy of Sponsor Study Records.
- Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement.
- Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills.
- Keep up to date with all the changes / required knowledge on ICH GCP, written standards and attending appropriate training sessions.