Overview
Senior Clinical Team Manager (CTM) role within PPD (a part of Thermo Fisher Scientific). The CTM combines deep knowledge, therapeutic expertise, and robust tools to help clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results; coordinating the activities of Clinical Management members allocated to a project on a Regional or Country basis. You work with the Project Manager to ensure training, tracking and quality systems are in place for the clinical management team and are primarily responsible for the clinical deliverables of the Project within agreed timelines and budget. Clinical Team Managers provide contact and support to the project sponsor for all clinical aspects.
Senior CTM - General Medicine (Dermatology, NASH, Cardiology, Nephrology) role at Thermo Fisher Scientific.
Responsibilities
* Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. May assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities such as process improvements, complex program management, or wider management tasks.
* Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) with the Data Quality Plan. Contributes to the Master Action Plan (MAP) for providing clinical documents. Ensures timely setup, organization, content and quality of relevant sections of the Trial Master File (local and central). May participate in design/development of CRFs, CRF guidelines, patient informed consent templates and other protocol documents. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defenses and hand-off meetings.
* Collaborates with the clinical team and other departments to meet project deliverables. Leads team meetings to maintain timelines, resources, interactions, and quality. Implements standardized clinical monitoring processes within the study and according to corporate policies. Responsible for timely archiving of documents and study materials.
* Ensures achievement of final clinical deliverables within contractual time, monitoring activity timelines and metrics, providing status updates to the project manager, and managing CRF collection and query resolution. Monitors trials to ensure contractual obligations are met. May conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
* Communicates with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
* Coordinates start-up activities and ensures essential document quality for Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) and follows up on ethics committee questions. Responsibilities may vary based on project timelines.
* Provides input into forecast estimates for clinical activities. Manages clinical resources, assignment, delegation of responsibilities, and identification of additional resource requirements.
Education and Experience
* Bachelor's degree or equivalent and relevant formal academic/vocational qualifications
* 5+ years of experience or equivalent combination of education, training and related experience
* Equivalency may be considered in some cases
Knowledge, Skills and Abilities
* Strong leadership and mentoring abilities; capable of motivating and integrating teams
* Excellent planning and organizational skills for prioritizing workload
* Strong interpersonal and problem-solving skills for working in a multicultural matrix organization
* Understanding of change management, clinical monitoring practices, and regulatory requirements (ICH/GCP, FDA, etc.)
* Strong judgment, decision-making, escalation and risk management skills
* Effective oral and written communication in English
* Ability to evaluate workload against project budget and adjust resources accordingly
* Financial acumen in budgeting, forecasting, and fiscal management
* Attention to detail
* Proficiency with standard office software and computerized systems
* Ability to independently manage clinical-only studies
Working Environment
* Values the health and wellbeing of employees; supports a healthy, balanced environment
* Ability to communicate with diverse groups and work in various environments
* Ability to work upright and stationary for typical working hours; non-traditional work environments acceptable
* Proficiency with standard office equipment; ability to work under pressure with multiple projects
* May be exposed to potentially hazardous elements in healthcare or laboratory settings
* Independent travel up to 20% (travel by car, plane, train)
Our 4i Values
* Integrity – Innovation – Intensity – Involvement
* If you resonate with our 4i values and wish to accelerate delivery of safe and effective therapeutics, submit your application.
We are unable to consider junior applications at this time.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Research and Science
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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