Clinical Team Manager (US Remote)
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center 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.
Responsibilities
Summary of Position
The Clinical Team Manager II provides project management expertise and leads a cross-functional team through all aspects of design, planning, startup, conduct, analysis, reporting and closeout of assigned clinical trials. Responsibilities including managing timelines, budgets, clinical sites, vendors and deliverables while maintaining quality and regulatory compliance. The Sr. CTM II typically works on the more complex and challenging clinical programs (i.e., global studies, late phase, multiple vendors, etc.).
Responsibilities and Job Duties:
Project Management- Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards.
Clinical Trial Planning- Provides overall operational and strategic input prior to commencement of clinical trials that include, but are not limited to: clinical planning tools, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, Investigator selection, systems (e.g., CTMS, IXRS etc.), clinical trial related operational manuals, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication etc. plans) site selection and budget planning. Directs Clinical Operations team members on daily tasks and activities.
Monitoring Activities- Oversee and directs other team members on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations.Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs Clinical Operations Director and other leadership (as appropriate) on overall clinical trial status and of potential issues/mitigation. May participate on site visits as needed or accompany junior team members for training purposes.
Site Management- Develops communication pathways and study specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training and IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations. Oversees set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance. Develops study training for study team, investigational sites, and vendors. Develops and oversees clinical site budgets, investigator payment processes and invoices related to projects assigned.
Vendor Oversight- Key decision maker in the selection of clinical service providerpersonnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel. Serves as the primary project contact for communication and coordination for the third-party vendors. Oversees themonitoring trip reports process and ensures resolution of all action items related to CROs. Ensures that vendors comply with all required standards and raises any issues and/or concerns. Oversee contract and budget preparation, negotiations and management throughout the trial life cycle
Internal/External Meetings- Facilitates Clinical Study Team meetings that comprise of cross functional representation. Ensures that study information is disseminated to the appropriate parties. Oversees and manages other meetings to include: internal team meetings, investigator meetings, and other trial- specific meetings as required.
Data Listing Review- Oversees in-house review of clinical data listings (protocol deviations, focused study data review, etc.) for completeness and accuracy and escalate issues as needed. Implements corrective actions to avoid or mitigate problems while considering the appropriate trade-offs of balancing risks with study deliverables and costs.
Trial Master File- Ensures that the study regulatory files are collected and inventoried and filed as per SOP requirements.
Ancillary Supplies- Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations.
Study Management Tools- Ensures that study teams and clinical sites have the appropriate study management tools to execute the study.
Clinical Operations Responsibilities - Act as a key contributor to the Clinical Operations department to include: clinical operations initiatives to streamline and improve processes, SOP development, Clinical Project Managers Forum, mentoring and developing Clinical Research Associates
Qualifications
Qualifications Include:
Education & Credentials
- Bachelor's degree in a relevant scientific discipline
Experience
Minimum of seven years of relevant clinical trial experience in the pharmaceutical or biotech industry with at least four of those years managing clinical trial activities.
Experience in oncology
Experience in global trials
Knowledge, Skills and Abilities
Thorough and integrated knowledge of the clinical trial process including cross-functional handoffs and dependencies
Advanced skills and through knowledge in regard to all clinical operations and site management activities
Advanced skills in Project Management, particularly in regard to management of schedule, budget, communication, resources and quality
Strong communication, and negotiation skills
Ability to influence without direct authority
Strong leadership skills including the ability to create a sense of clear direction
Ability to travel to meetings, sites and vendors approximately 10-20%
Supervisory Responsibilities
- None at this time
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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Posted Date 1 day ago (11/21/2022 4:25 PM)
ID 2022-97082
Location : Location US-Remote