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
Create a job alert for this search
Clinical Clinical • India
Related jobs
Clinical Trial Regulatory Manager
Stryde Research • Republic Of India, IN
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey.
M+ patients through 100+ specialized clinics with d...Show more
Last updated: 6 hours ago • Promoted • New!
Manager, Clinical Data Strategies
IQVIA India • Cochin, Republic Of India, IN
Manager, Clinical Data Management.Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements.
Provide expert review and guidance for pr...Show more
Last updated: 30+ days ago • Promoted
Senior Clinical Data Programmer
Capgemini Engineering • Republic Of India, IN
Looking for only 7+yeras of experience.This Job requires you to work from PAN India Capgemini office.The Statistical Programmer II (SP II).
Programs all tables, listings and graphs necessary for an ...Show more
Last updated: 20 days ago • Promoted
Clinical Coordinator
Luma fertility • Republic Of India, IN
About Us : Luma Fertility is a next-generation fertility company founded by second-time entrepreneur Neha Motwani and backed by Peak XV Partners.
We are redefining fertility care through science, com...Show more
Last updated: 16 days ago • Promoted
Clinical Study Senior Program Manager
Tech Observer • Republic Of India, IN
Contract Research Organization (CRO) with a presence in over 20+ countries, is currently hiring.Clinical Research Associates (CRAs).
We are looking for candidates with strong experience as a.Clinica...Show more
Last updated: 8 days ago • Promoted
Clinic Manager
Skinfiniti Aesthetic skin and laser clinic, Khar, Mumbai • Republic Of India, IN
Skínfinitii Aesthetic Skin & Laser Clinic is a highly reputed centre known for its ethical dermatology, evidence-based aesthetic treatments, and excellent patient care.
The clinic maintains stringen...Show more
Last updated: 6 hours ago • Promoted • New!
Clinical Trial Assistant
ClinoGenesis Research Institute • Republic Of India, IN
Clinical Trial Assistant (CTA).Clinogenesis Research Organisation.At Clinogenesis Research Organisation, the Clinical Trial Assistant (CTA) will support clinical operations and contribute to the su...Show more
Last updated: 22 hours ago • Promoted • New!
Clinical Study Support Specialist
ClinoGenesis Research Institute • Republic Of India, IN
Clinical Trial Assistant (CTA).Clinogenesis Research Organisation.At Clinogenesis Research Organisation, the Clinical Trial Assistant (CTA) will support clinical operations and contribute to the su...Show more
Last updated: 22 hours ago • Promoted • New!
Clinical Research Associate
HINDCO Consulting Services • Pune, Republic Of India, IN
Manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures.Conducts research to ensure these products are safe.
Ordering, tracking, and manag...Show more
Last updated: 22 days ago • Promoted
Clinical Coordinator
Confidential • India
Zyla Health is India's highest-rated personalized care management platform focused on improving health outcomes.Zyla enables care at scale for insurers and employers through its human-assisted AI o...Show more
Last updated: 10 days ago • Promoted
Clinical Trial Coordinator
Confidential • India
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.Our global Clinical Operations colleagues within our PPD® clinical research services prov...Show more
Last updated: 16 days ago • Promoted
Clinical Research Regulatory Coordinator
Stryde Research • India, India
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey.
M+ patients through 100+ specialized clinics with d...Show more
Last updated: 6 hours ago • Promoted • New!
Clinical Operations Senior Project Lead
Tech Observer • Republic Of India, IN
Contract Research Organization (CRO) with a presence in over 20+ countries, is currently hiring.Clinical Research Associates (CRAs).
We are looking for candidates with strong experience as a.Clinica...Show more
Last updated: 8 days ago • Promoted
Clinical Coordinator (Freelance)
Confidential • India
Job Type : Independent Contractor / Freelance Location : 100% Remote (Must be based in Kerala / India) Availability : Intermittent, On-Call (Primarily Evening Shift Support) Compensation : Competitive Mo...Show more
Last updated: 6 days ago • Promoted
Associate US Clinical Recruitment Coordinator
Generis Tek Inc • Pune, Republic Of India, IN
Please Contact : To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Ragini Sharma.Permanent role for a US Clinical / Pharma / Healthcare Recruiter f.Please let me know i...Show more
Last updated: 30+ days ago • Promoted
Pilot Research Coordinator
HosTalky® • India, India
Job Type : Part-Time / Full-Time.In healthcare, every second counts — yet millions of professionals lose precious time to fragmented communication tools.
At HosTalky, we’re fixing that.We’re building...Show more
Last updated: 1 day ago • Promoted
Clinical Research Compliance Coordinator
Stryde Research • Republic Of India, IN
We're a Site Management Organization operating 20+ clinical research sites across Dallas-Fort Worth, Houston, Louisiana, New York, and New Jersey.
M+ patients through 100+ specialized clinics with d...Show more
Last updated: 6 hours ago • Promoted • New!
Operations Manager - Clinical SAS Programming
ApicalGo Consultancy • India
Job Summary : We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS ...Show more
Last updated: 30+ days ago • Promoted