Homeoffice Centralized CTL I en Fortrea

Summary of Responsibilities:

• Management of projects under direction of a Project Manager/Director as assigned.
• Ensure site monitoring responsibility for clinical studies is conducted according to Fortrea Standard Operating Procedures (SOP), ICH Guidelines and GCP.
• 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).
• Proactively identified opportunities for process improvements and work collaboratively with project team in case further action required.
• Complete required training within timelines and ensure training resources are up to date with changes in procedures.
• Follow applicable departmental SOPs and Work Instructions.
• Follow project issue escalation process and Fortrea Corrective action issue resolution process for clinical operations issues.
• 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.
• Proactively identify risks and report them to the study team.
• Responsible for timely and appropriate communication to the clinical operations team.
• Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
• Review progress of project and initiate appropriate actions to achieve target objectives assigned.
• Support in review of SOPs or Work Instructions to align with process or tool modifications.
• Review and support development of training material and plans to support the training requirements of the department.
• Support study team for CQC visits for local or regional clinical trial sites, if needed.
• Other duties as assigned by management: Ex Trip Report templates and guidelines creation, Document Review, ETMF reconciliation, PD review and trending, Issues review and management, PSV/SIV slide deck creation, CRA training, other CTL tasks.
• Train and mentor CRAs and IHCRAs in different areas, as needed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (e.g., Nursing Certification, Medical or Laboratory Technology).
• Minimum 8 years' work experience in clinical research, including a strong working knowledge of ICH-GCP guidelines and all other applicable guidelines and regulations.
• 2 years' experience in Trip Report review is ideal.
• In Lieu of this requirement, candidates with 8+ years of relevant clinical research experience in pharmaceutical or CRA industries may be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• Minimum 2 Years of experience in the job discipline (Inclusive of Trip report review experience).
• Minimum 8 years of Clinical experience.
• Working knowledge of ICH GCP including internal regulatory requirements for the conduct of clinical development programs.
• Advanced computer skills (e.g., MS Office Suite - Word, Excel, PowerPoint presentation).
• Other required work-related experience:
• Demonstrated ability to plan, prioritize, organize, and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Strong interpersonal skills with ability to work well with others.
• Ability to influence and lead.
• Ability to facilitate meetings.
• Ability to be part of process improvement initiatives.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.

Physical Demands/Work Environment:

• General office environment.
• Candidate may be home-based if business demands for it.
• Candidates should be able to work in shifts, if required, and be ready to work extended hours.
• May involve extensive use of computer and keyboard.
• Some Domestic Travel may be required.

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