Covance

Centralized Trip Report Reviewer (Clinical Operations)

Job Location(s) IN-Bangalore
Job Number
2021-58668
Job Category
Clinical Operations Management
Position Type
Full-Time
Telecommute
Yes

Job Overview

Job location: Homebased, India
 
- Management of complex projects under direction of a Project Manager / Director as assigned.
- Ensure site monitoring responsibility for clinical studies are conducted according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.
- Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned (Implementation of Initiatives either independently or with team)
- Proactively identifies opportunities for process improvements and work collaboratively with project team incase further action required
- Complete required trainings according to required timelines.
- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Proactively identifies opportunities for process improvements. Lead the process improvement opportunities and manage the implementation of associated revised processes and procedures.
- Follow project issue escalation process and Labcorp Corrective Action Issue Resolution (CAIR) 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
- Responsible for the 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.
- TRRII is also the main point of contact for communication with the Global CTLs/PMs.
- Mentoring and training of new TRRs on trip report review processes as per ICH-GCP and in house SOPs and local work instructions
- Performing quality check of the work ofnew TRRs as a part of mentoring.
- Review and support development of training material and plans to support the training requirements of the department.
- Ensure training resources are kept up to date with changes in procedures
- Other duties as assigned by management: Ex- Document Review, ETMF reconciliation, other CTL tasks etc.
Experience:
- Years of experience in the job discipline: 00-02 Years (inclusive ofTRR experience)
- Years of experience in other professional roles: 10+ Years
- Other required work-related experiences:
- Act as an SME and lead initiatives
- Thought Leader in providing Industry trends
- Ability to Influence stakeholders
- Mentor Delivery teams and cross departmental synergies of 4
- 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 deliver consistent high quality of work.
- Ability to use computer and departmental tools.
- Strong interpersonal skills.
- Ability to negotiate/lnfluence with others.

Education/Qualifications

University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 10+ years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations. Exclusive Trip Report Review experience of 02+ years us must.
In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.

Experience

Minimum Required:
- Years of experience in the job discipline: 00-02 Years (inclusive ofTRR experience)
- Years of experience in other professional roles: 10+ Years
- Other required work-related experiences:
- Act as an SME and lead initiatives
- Thought Leader in providing Industry trends
- Ability to Influence stakeholders
- Mentor Delivery teams and cross departmental synergies of 4
- 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 deliver consistent high quality of work.
- Ability to use computer and departmental tools.
- Strong interpersonal skills.
- Ability to negotiate/lnfluence with others.

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