Talent.com
Sr Clinical Trial Coordinator / Clinical Trial Coordinator II

Sr Clinical Trial Coordinator / Clinical Trial Coordinator II

ConfidentialIndia
10 days ago
Job description

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

  • A 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

    • Education Requirements

  • Graduate / Bachelor's degree in life sciences or other related field.

    • Experience

  • 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.

    • Other Job-Related Skills

  • 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.

    • What We Offer

  • Chance to participate in groundbreaking treatments.
  • Comprehensive training and development programs.
  • A collaborative and inclusive work environment.
  • Attractive compensation and comprehensive perks.

    • Working Conditions and Environment

  • 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.

    • Skills Required

    Project Management, Microsoft Office, Advanced Excel

    Create a job alert for this search

    Clinical Clinical • India

    Related jobs
    • Promoted
    Associate / Sr Associate _ Data Analytics & Business Strategy

    Associate / Sr Associate _ Data Analytics & Business Strategy

    AmherstNagpur, IN
    Amherst Residential Amherst is revolutionizing the way U.Driven by data, analytics, and technology, Amherst has a 20-year history of anticipating where the next risks and opportunities are likely t...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Research Coordinator

    Clinical 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 moreLast updated: 17 days ago
    • Promoted
    Research Coordinator-Microbiome & Disease / Clinical & Microbiome Study Specialist

    Research Coordinator-Microbiome & Disease / Clinical & Microbiome Study Specialist

    Decode AgeNagpur, IN
    Research Coordinator-Microbiome & Disease / Clinical & Microbiome Study Specialist.Science- Research & Development.We are seeking a scientifically driven, detail-oriented individual to join our dise...Show moreLast updated: 1 day ago
    • Promoted
    RCM Associate

    RCM Associate

    EMPClaimsNagpur, IN
    EMPClaims was recently recognized as a Top 10 vendor for RCM Services in the US, and we take pride in the quality of our services. Our customers include large health systems and small medical practi...Show moreLast updated: 1 day ago
    • Promoted
    Manager / Sr. Manager

    Manager / Sr. Manager

    MedantaNagpur, IN
    Over the past 15 years, Medanta has created an unrivalled impact in delivering world class multi-specialty care for patients in India. We have hospitals in Gurgaon, Lucknow, Patna, Indore, Ranchi & ...Show moreLast updated: 1 day ago
    • Promoted
    Associate Director - Clinical Operations

    Associate Director - Clinical Operations

    Elevate NowIndia
    Elevate Now is India’s first doctor-led medical weight-loss company, delivering evidence-based care through obesity medicine, GLP-1 protocols, metabolic diagnostics, and lifestyle coaching.We treat...Show moreLast updated: 1 day ago
    • Promoted
    Quality Assurance Auditor

    Quality Assurance Auditor

    K3-Innovations, Inc.Nagpur, IN
    Job Title : Clinical Quality Compliance Manager.Location : Bengaluru, Karnataka, India.QA / Compliance Director or Clinical Operations Director. Clinical Site Auditor to ensure compliance and quality at...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Coordinator

    Clinical Coordinator

    ConfidentialIndia
    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 moreLast updated: 4 days ago
    • Promoted
    Sr. Analyst or Associate

    Sr. Analyst or Associate

    Tequity AdvisorsNagpur, IN
    Tequity Advisors is dedicated to achieving the best outcomes for our clients through successful M&A transactions within Cloud, SaaS, and IT ecosystems. Leveraging our deep industry knowledge and glo...Show moreLast updated: 2 days ago
    • Promoted
    Program Coordinator - Global Delivery

    Program Coordinator - Global Delivery

    EmeritusNagpur, IN
    Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 7 days ago
    • Promoted
    • New!
    Product Manager

    Product Manager

    Tilda ResearchNagpur, IN
    Product Manager (AI for Clinical Research).We're looking for a Product Manager who combine.You'll work directly with the founders to shape our product strategy, prioritize features that deliver imm...Show moreLast updated: 15 hours ago
    • Promoted
    Clinical Trial Coordinator

    Clinical Trial Coordinator

    ConfidentialIndia
    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 moreLast updated: 10 days ago
    • Promoted
    • New!
    Clinical Coordinator (Freelance)

    Clinical Coordinator (Freelance)

    ConfidentialIndia
    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 moreLast updated: 7 hours ago
    • Promoted
    Sr. Corp TA

    Sr. Corp TA

    ConfidentialIndia
    TaskUs is a provider of outsourced digital services and next-generation customer experience to fast-growing technology companies, helping its clients represent, protect and grow their brands.Levera...Show moreLast updated: 11 days ago
    • Promoted
    Statistical Programmer II

    Statistical Programmer II

    ConfidentialIndia
    The Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Statistical Programmer

    Senior Statistical Programmer

    Capgemini EngineeringNagpur, 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 moreLast updated: 15 days ago
    • Promoted
    Clinical Research & Partnerships Associate (MBBS)

    Clinical Research & Partnerships Associate (MBBS)

    Smart Mirror.LLCNagpur, IN
    Clinical Research & Telehealth Partnerships Associate (MBBS).WFH, 12 : 00 to 9 : 00 while in office.MBBS graduates are also encouraged to apply—especially those looking to transition into.Clinical Rese...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Trial Manager (Hyderabad)

    Clinical Trial Manager (Hyderabad)

    ConfidentialIndia
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...Show moreLast updated: 16 days ago