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 will you be doing?
As a Clinical Team Manager, you will be responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets.
The Clinical Team Manager is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations)
May be required to take-on the Dedicated Project Expert (DPE) role depending on Clinical Team Manager’s level of experience, relevant skill-set and business needs.
Responsibilities:
- Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor
activities and deliverables (i.e., Central Lab, IVRS, data management, monitoring Meeting Planner). Liaise with coding and TIM representatives when applicable.
- Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product. Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the CTT. Review other CTT and vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality). Ensure appropriate testing/UAT are performed as required (e.g. eCRF screens, database structure, data loading, etc).
- Ensure proper collection and validation of data and documentation on a timely manner. Assure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures. Perform patient data validation homogeneously and fulfilling required quality standard. Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required.
- Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits to CSU’s, training of monitoring teams, investigator meetings. CRO management if applicable. Prepare and lead data review meeting, organize and contribute to medical review meetings.
- Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
- Collaborate with the CSP to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process.
- Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done, in collaboration with the Clinical Purchasing department
- Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to CTT and/or DPE and Team Leader. Develop and implement immediate action plan at global CSU/sites level if needed
- Upon request, prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. Polaris BO reports, etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRS meetings to optimize monitoring efficiency & quality
- Participate, as a delegate to TL, to the training of new Clinical Team Managers on therapeutic area and general responsibilities within their function
- Dedicated Project Expert (DPE) role: The Dedicated Project Expert (DPE) is a role performed by a senior Clinical Trial Manager (CTM), senior Study Data Manager (SDM) or senior Clinical Team Manager in addition to his/her direct study responsibilities; direct study responsibilities may be adjusted depending on the coordination activities workload of the designated clinical program. The DPE is accountable for operational oversight of the clinical program conducted within Trial Operations. He/she coordinates with CTM(s), SDM(s) and Clinical Team Manager(s) working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with good quality.
The DPE assists the CSO CSP Project Leader (PL) in developing/ following the execution of the program operational statement. The DPE is the primary point of contact for PL within TO and will represent CTMs/SDMs/Clinical Team Managers working on program as the designated CSO CSP Project Team Member. He/she is the primary responsible person for escalation of program issues/information within Trial Operations and will ensure that PL and TL are being provided with regular reporting on the program progress. The DPE provides input to help TL ensure alignment according to risk adjustment and study milestones.
What do you need to have?
Education:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
Skills:
- 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
- Read, write and speak fluent English; fluent in host country language required.
- Experience in managing all trial components (start-up to database lock) preferred
- Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred
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.
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