Local Ctm/delivery Lead, Fsp

4 weken geleden

Amersfoort, Nederland Thermo Fisher Scientific Voltijd

**Work Schedule**

Other

**Environmental Conditions**

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

FSP (Functional Service Partnership) is a partnership between Thermo Fisher Scientific and our clients. In this position, employees will be sourced to work with a specific client.

**Discover Impactful Work**:
Accountable for achieving the final clinical result (usually clean data from evaluated patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.

**A day in the Life**:

- Runs all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents.
- Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
- Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborates with the clinical team and other departments as needed to meet deliverables of the project.
- Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
- Responsible for the timely archiving of documents and study materials for the department.
- Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and leading CRF collection and query resolution.
- Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed.
- Ensures that essential document quality meets the expectation of Regulatory Compliance Review.
- Reviews and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

**Keys to Success**:
**Education**:

- Bachelor's degree or equivalent and relevant for

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