Fsp Clinical Trial Coordinator

hace 2 meses

Desde casa, México Thermo Fisher Scientific A tiempo completo

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Purpose**:

- Clinical Trial Coordinator - Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
- CTC role was implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across business, with a focus on increasing operational delivery efficiency.

**A day in the life**:

- Project Specialist works in close partnership with the Study Manager or Study Delivery Lead on end-to-end operational study delivery activities, from study set up to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems/databases/tracking tools and project plans (CSAP).
- CTC is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.
- CTC - Project Specialist is responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies.
- CTC is responsible for facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies.
- CTC is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
- CTC is responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status.
- CTC is responsible for coordinating study-related activities and managing study team's communication - meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists.
- CTC is responsible for overseeing delivery of clinical supplies, investigational products and all study materials provided by the Sponsor or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate.
- CTC-Project Specialist is responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.
- CTC is responsible for budget oversight - managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements.

**Education Requirements**
- Graduate/Bachelor's degree in life sciences or another related field

**Experience**
- Graduate or Bachelor level with at least 1+ years of relevant work experience in a pharmaceutical/scientific environment.
- Scientific background and knowledge of clinical trials (including ICH-GCP) and drug development process is an asset.
- Foundational knowledge of clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard.
- Strong project management skills (preferably with analytical/financial skills).
- Excellent verbal and written communication in English.
- Excellent communication and relationship building skills.

**Other Job-Related Skills**:

- Good knowledge of, and skills in applying, applicable clinical trial regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills.
- Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach.
- Logical/analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training skills.
- Good understanding of the principles of project planning and project management.
- Basic knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
- Very good comprehension of Microsof

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