Senior Centralized Study Specialist

hace 2 semanas

Bogotá, Colombia INGEPSY A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are seeking an experienced and highly motivated Senior Centralized Study Specialist to join our team. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.

Key Responsibilities:

Clinical Systems Management:

  1. Manage clinical systems, including CTMS milestone updates at Site / Country / Protocol levels.
  2. Manage and review study documents and support eTMF management.
  3. Manage internal / external communications by publishing and distributing newsletters, memos, and global communication under the guidance of the PM team.
  4. Create study plans and templates, including drafting and final formatting of slide decks for meetings, monitoring plans, etc.

Data Review:

  1. Follow up with CRAs for resolution of outstanding issues / action items related to assigned tasks.
  2. Perform Associate Lead / Lead role for assigned projects.
  3. Draft and send study-specific reports as per study team instructions.
  4. Collaborate with Data Management and Programming teams for reports and communication of data review-related tasks.
  5. Initiate standardization of processes across different studies within data review.
  6. Perform quality reviews and suggest metrics improvements for data review tasks.
  7. Train, coach, and mentor new team members on all data review-related tasks.
  8. Perform other data review-related tasks as instructed by the project team and manager.

Document Review:

  1. Review Initial / Amended Investigator Packages for regulatory compliance before granting green light for site patient enrollment.
  2. Review Core / Country / Site Informed Consent Forms for compliance with sponsor and regulatory requirements, and GCP guidelines.
  3. Review patient recruiting materials (advertisements) for compliance with sponsor, regulatory requirements, and GCP guidelines.
  4. Review Core Protocols for thoroughness, completeness, and GCP compliance.
  5. File informed consent forms, patient recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
  6. Draft Investigator Package Plans documenting required quality of documents included in Investigator Packages with manager oversight.
  7. Provide input for CAPAs related to document review activities.
  8. Review CSSP Country and Site Document Review activities to ensure regulatory compliance and adherence to departmental processes.

General Responsibilities:

  1. Follow all applicable departmental SOPs and Work Instructions.
  2. Complete required trainings within specified timelines.
  3. Create, review, and revise training materials and plans to support departmental training requirements.
  4. Create, review, or revise SOPs or Work Instructions to align with process or tool modifications.
  5. Manage day-to-day tasks ensuring quality and productivity.
  6. Generate monitoring processes to ensure trainee competence.
  7. Manage project and technical documentation appropriately.
  8. Provide administrative and technical support to internal departments and teams as needed.
  9. Perform checks to ensure the quality of completed work.
  10. Execute high-quality, timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.
  11. Work on multiple studies and prioritize tasks as needed.
  12. Ensure timely escalation and issue resolution.
  13. Track and report metrics as determined by management.
  14. Identify opportunities and lead the implementation of process enhancements.
  15. Support the implementation of tools internally to enhance deliverables.
  16. Effectively mentor and train others.
  17. Work with global stakeholders.
  18. Assist in document management (including document template creation, collection, review, processing, and tracking up to eTMF filing) for all documents within agreed processes / activities or within the scope of GSDM throughout the study duration.
  19. Assist in preparing new investigator submission packages for site / regulatory submission.
  20. Support study teams for contracts and budget activities for investigative sites, including investigator payment, pass-through payment processing, and tracking.
  21. Assist study start-up teams with site start-up activities.
  22. Review, support, manage, or assist in managing site clinical trial contracts in accordance with defined processes and timelines.
Qualifications (Minimum Required):

Education:

University / College Degree in Life Sciences or a related field, or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or Laboratory Technology). Relevant and equivalent experience may be considered in lieu of educational requirements.

Experience:

4-5 years of work experience in clinical research. Strong working knowledge of ICH-GCP guidelines and other applicable regulations.

Skills:

Demonstrated ability to plan, prioritize, organize, and communicate effectively. Attention to detail and high-quality work delivery. Strong interpersonal skills and ability to work collaboratively. Ability to influence and lead others. Ability to facilitate meetings. Experience in leading process improvement initiatives. Ability to mentor and train others.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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