Clinical Trial Compliance Officer

18 hours ago

Tiruppur, Tamil Nadu, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000
Job Title: Quality Assurance Specialist

The successful candidate will oversee end-to-end clinical trial activities from a quality perspective, ensuring compliance with applicable regulations and guidelines.

This role involves reviewing all study-related activities, processes, procedures, and adherence to relevant regulations and guidelines to ensure inspection readiness.

Key responsibilities include:

  • Developing and implementing a risk-based approach to quality compliance within the function, safeguarding trial participants and data in compliance with regulatory requirements.
  • Identifying team member training requirements and maintaining oversight of training to ensure all members are trained on each SOP as required.
  • Preparing standard operating procedures (SOPs) related to quality functions and supporting review of SOPs specific to Medical Science, Clinical Team, and Data Management Teams.
  • Quality review of clinical trial medical science-related activities such as Synopsis, Protocol, Clinical Study Report (CSR), and appendices, and SOPs in line with ICH GCP requirements, Indian, and global regulatory requirements.

Required Skills:

  • 5 years' experience in a CRO/Pharma/Biotech organization in the Quality department with experience of quality activities in Clinical Research Department.
  • Strong eye for detail and ability to spot inconsistencies, good conflict management skills, and experience in handling audits & inspections of DCGI, US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.

  • Statistical Analyst

    1 week ago

    Tiruppur, Tamil Nadu, India beBeeBiostatisticians Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

    Senior Biostatistician RoleThe Senior Biostatistician plays a pivotal role in spearheading statistical strategies to support clinical trials.This position contributes to the planning, execution, and interpretation of statistical analyses across development programs under the guidance of the Head of Biostatistics.Main Responsibilities:Lead biostatistical...

  • Oncology Clinical Trials Lead

    2 days ago

    Tiruppur, Tamil Nadu, India beBeeClinicalTrialManager Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Clinical Research Professional Opportunity\We are seeking an experienced Clinical Trial Manager to lead the execution of Phase I, II and III oncology studies at key national institutions in India.\About This Role:\\Lead clinical operations and site-level engagement for assigned Phase's studies in India\Manage relationships with Principal Investigators (PIs),...

  • Senior Clinical Operations Manager

    1 day ago

    Tiruppur, Tamil Nadu, India beBeeClinicalResearch Full time ₹ 20,00,000 - ₹ 23,00,000

    Job DescriptionThe Senior Manager of Clinical Research is responsible for leading and managing clinical trials and research studies.Clinical Trial Management:Plan, initiate, and manage clinical research projects from start to finish.Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.Ensure...

  • Clinical Document Authoring Specialist

    7 days ago

    Tiruppur, Tamil Nadu, India beBeeClinical Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Clinical Research AssociateWe are seeking a skilled Clinical Document Authoring Specialist to join our team. This role involves the creation, analysis, and refinement of clinical trial documents, including protocols, informed consent forms, and clinical study reports.Key Responsibilities:Author and analyze clinical trial documents, including...

  • Lead Statistician

    1 day ago

    Tiruppur, Tamil Nadu, India beBeeStatistical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Senior Clinical Statistical ProgrammerLocation: Remote (Work from Home)Experience: 5+ yearsJob Responsibilities:Technical LeadershipStrong oral and written communication skillsExperience in handling complex efficacy domains and TFLsAct as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve...

  • Embark on a Fulfilling Career as a Clinical Research Associate

    7 days ago

    Tiruppur, Tamil Nadu, India beBeeClinicalResearch Full time ₹ 40,00,000 - ₹ 80,00,000

    Launch Your Career in Clinical ResearchClinogenesis Research Organization is offering an exciting opportunity for fresh graduates to launch their careers as a clinical research associate.This role is designed for individuals who are passionate about clinical research and eager to grow in a structured, accredited environment.The selected candidate will work...

  • Clinical Quality Assurance Specialist

    6 days ago

    Tiruppur, Tamil Nadu, India beBeeQuality Full time ₹ 60,00,000 - ₹ 80,00,000

    Job OverviewWe are seeking an experienced Quality Assurance specialist to provide day-to-day clinical quality assurance support across ongoing clinical trials.

  • Senior Clinical Systems Tester

    7 days ago

    Tiruppur, Tamil Nadu, India beBeeClinical Full time ₹ 1,00,00,000 - ₹ 1,45,00,000

    Job Summary:We are seeking a Clinical Systems Tester to support our Decentralized Clinical Trial environment. This role involves testing and validation activities across various digital systems and patient-facing technologies.Key Responsibilities:Author and execute test scripts in Veeva EDC, aligned with protocol requirementsValidate workflows across eCOA...

  • Advanced Clinical Data Analyst

    6 days ago

    Tiruppur, Tamil Nadu, India beBeeStatistical Full time ₹ 1,20,00,000 - ₹ 1,60,00,000

    Senior Statistical ProgrammerThis is an exciting opportunity to leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead clinical trials. The successful candidate will work closely with our client, with our support behind them.Key Responsibilities:Perform data manipulation, analysis and reporting of...

  • Clinical Data Operations Manager

    6 days ago

    Tiruppur, Tamil Nadu, India beBeeDataManagement Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Job Summary:Clinical Data Management SpecialistThis role is responsible for defining project specifications, including protocol conversion and database build. Strong understanding of data collection and integration into clinical trials required.Key performance indicators (KPIs) will be monitored to ensure accurate and relevant data is delivered on...