Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
Conduct remote visits/contacts as requested/needed.
Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
Follow-up on CRF data entry, query status, and SAEs.
Conduct on-site study-specific training (if applicable).
Perform site facilities assessments
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality,



and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
Show commitment and perform consistent high-quality work.
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and productive delivery.
Provide input and feedback for Performance Development Conversation(s).
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
Flexible attitude with respect to work assignments and recent learning.
Ability to prioritize multiple tasks and achieve project timelines; Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
Developing ability to work across cultures.
Shows commitment to and performs consistently high-quality work.
Ability to successfully work in a ('virtual') team environment.
Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
Holds a driver's license where required.
Knowledge And Experience
~ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience

📌 Remote CRA - Flexible working (Bengaluru)
🏢 Parexel
📍 Bengaluru