Sr Clinical Trial Coordinator / Clinical Trial Coordinator IIConfidential • India
Sr Clinical Trial Coordinator / Clinical Trial Coordinator II
Confidential • India
16 days ago
Job descriptionA day in the life : Project Specialist works in close partnership with the Study Manager or Study Delivery Lead on end-to-end operational study delivery activities, from study set up to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP). CTC works cross-functionally, with internal and external partners, on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with STOM, current clinical study regulations, policies, best practices and standards, and plays a key role in successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study. CTC is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks / issues which may impact delivery of the study to the necessary quality, timeline and budget objectives. CTC is responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies. CTC is responsible for facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies. CTC is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties. CTC is responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status. CTC is responsible for coordinating study-related activities and managing study team's communication – meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists. CTC is responsible for overseeing delivery of clinical supplies, investigational products and all study materials provided by the Sponsor or external service providers and communicating issues / risks to continuity of supplies and proposing solutions as appropriate. CTC is responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality. CTC is responsible for budget oversight – managing Task / Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the SDL. CTC actively contributes to the squads as per STOM requirements Graduate / Bachelor's degree in life sciences or other related field. At least 4+ years of relevant work experience in a pharmaceutical / scientific environment. Knowledge of clinical trials, ICH-GCP guidelines, and drug development processes. Strong project management skills with an analytical / financial background. Proficiency in using key systems for clinical trial delivery, including Trial Master File standards. Excellent verbal and written communication skills in English. Expertise in clinical trial regulatory requirements (GCP and ICH guidelines). Ability to manage multiple competing priorities with strong planning and time management skills. Logical and analytical thinking with a focus on quality and attention to detail. Proficiency with Microsoft Office tools and advanced Excel. Excellent collaborator management and interpersonal skills. Goal-oriented and flexible in response to evolving situations. Collaboration and working effectively across diverse cultures and locations. Chance to participate in groundbreaking treatments. Comprehensive training and development programs. A collaborative and inclusive work environment. Attractive compensation and comprehensive perks. Work is performed in an office, laboratory, clinical, and / or home office environment with exposure to electrical office equipment. Occasional travel to site locations may be required. This position is remote.
Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Overview
- Clinical Trial Coordinator – Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
- CTC role was implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across business, with a focus on increasing operational delivery efficiency.
Responsibilities
Education Requirements
Experience
Other Job-Related Skills
What We Offer
Working Conditions and Environment
Skills Required
Project Management, Microsoft Office, Advanced Excel
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