Centralized Clinical Team Lead-II

2 weeks ago

Bengaluru, Karnataka, India Fortrea Full time

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.


Management of complex projects under direction of a Project Manager/Director as assigned.
2. Ensure site monitoring responsibility for clinical studies are conducted according to Fortrea
Standard Operating Procedures, ICH Guidelines and GCP
3. Work closely with project teams in implementation of best trip report review practices and
applicable project plans as assigned (Implementation of Initiatives either independently or with
team)
4. Proactively identified opportunities for process improvements and work collaboratively with
project team incase further action required.
5. Complete required trainings according to required timelines.
6. Follow applicable departmental Standard Operating Procedures and Work Instructions.
7. Proactively identified opportunities for process improvements. Lead the process improvement
opportunities and manage the implementation of associated revised processes and procedures.
8. Follow project issue escalation process and Fortrea Corrective action issue resolution process for
clinical operations issues.
9. Ensure follow up on issues and risks and protocol deviations and to be a liaison between CRA,
CTL and PM for timely resolution of issues.
10. Proactively identify risks and report them to the study team.
11. Responsible for timely and appropriate communication to the clinical operations team.
12. Liaise with CTL/PM to communication any trends, outstanding issues, safety concerns or any other
activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
13. Review progress of project and initiate appropriate actions to achieve target objectives assigned.
14. cCTL-II is also the main point of contact for communication with the Global CTLs/PMs
15. Mentoring and training of new cCTL on trip report review processes as per ICH-GCP and SOPs
and local work instructions.
16. Performing quality check of work of new cCTL as a part of mentoring.
17. Review and support development of training material and plans to support the training requirements
of the department.
18. Ensure training resources are up to date with changes in procedures.
19. Support study team for CQC visits for local or regional clinical trial sites, if needed.
20.

Other duties as assigned by management:
Ex Trip report Template and guideline creation,
Document Review, eTMF reconciliation, PD review and trending, PSV/SIV slide deck creation,
CRA training, other CTL tasks.

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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