Clinical Compliance Specialist

13 hours ago

Bellary, Karnataka, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Clinical Compliance Specialist

Experience: 5 plus years in Quality Assurance and Compliance.

Location: Mumbai, India

Type: Full-time employment opportunity.

Experience Level: Senior level professional.

Department: Clinical Research Department

Purpose of this Role:

This senior level role will be responsible for overseeing end-to-end clinical trial activities from a quality compliance perspective. The selected candidate will be accountable for ensuring Quality Compliance (QC) activities across multiple teams, including Clinical Trial Medical Science, Operations, Clinical Trial Supply Management (CTSM), and Clinical Data Management. This will involve reviewing study-related activities, processes, procedures, and adherence to applicable regulations and guidelines to ensure continuous inspection/audit readiness.

Main Responsibilities:

  • Develop and implement a risk-based approach to Quality Compliance (QC) within the function, which ensures trial participants and data are safeguarded in compliance with regulatory requirements and best practices.
  • Identify and decide team member's job specific SOP training requirements, maintaining oversight of training to ensure all team members are trained on each SOP as required.
  • Preparation and review of SOPs related to QC function, supporting review of SOPs specific to Medical science, Clinical team, and Data Management team.
  • Quality review of clinical trial medical science related activities, such as Synopsis, Protocol, Clinical Study Report (CSR), and appendices, as well as SOPs in line with ICH GCP requirements, Indian and global regulatory requirements.
  • Quality review of clinical trial operation related activities, tools, plans, and documentation, including site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site specific reports, Site Documents, logs, and close out activities in line with ICH GCP requirements, Indian and global regulatory requirements.

Requirements and Qualifications:

  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
  • Strong eye for detail, ability to spot inconsistencies, and good conflict management skills.
  • Must have experience 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.
  • Experience working in matrix business environments preferred.
  • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.

  • Clinical Specialist

    1 week ago

    Bellary, Karnataka, India beBeeCare Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Medical Professional OpportunityDenvax Cancer Center, Vasant Vihar, New DelhiAbout UsWe are India's pioneers in dendritic cell cancer immunotherapy. Our state-of-the-art facility houses a nursing home with an ICU unit, delivering advanced, patient-centered care exclusively to cancer patients.Job SummaryWe are seeking a highly skilled medical professional to...

  • Clinical Document Specialist

    7 days ago

    Bellary, Karnataka, India beBeeClinicalResearch Full time ₹ 9,00,000 - ₹ 18,00,000

    As a Clinical Research Associate, you will play a crucial role in the success of clinical trials.Key Responsibilities:Author and analyze clinical trial documents, including protocols, informed consent forms, and clinical study reports.Ensure accuracy and compliance with global regulatory standards (FDA, EMA, ICH-GCP).Create, validate, and refine prompts for...

  • Clinical Research Document Specialist

    7 days ago

    Bellary, Karnataka, India beBeeScientist Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title:">Clinical Research Document SpecialistAs a Clinical Research Document Specialist, you will be responsible for creating high-quality clinical trial documents that support drug development and regulatory submissions.">Key Responsibilities:Translate complex scientific data into clear, concise documents that meet regulatory requirements.Develop...

  • Senior Pre-Clinical Pathology Specialist

    1 day ago

    Bellary, Karnataka, India beBeeLaboratory Full time ₹ 9,00,000 - ₹ 12,00,000

    **Pre-Clinical Pathology Laboratory Specialist**This position requires a highly skilled and experienced individual to lead our pre-clinical pathology lab. Key responsibilities include:Planning and execution of blood collection from various laboratory animalsMonitoring anesthesia / euthanasia of laboratory animalsPreparing and conducting necropsy examinations...

  • Clinical Data Manager

    1 week ago

    Bellary, Karnataka, India beBeeData Full time ₹ 15,00,000 - ₹ 20,00,000

    Clinical Data Management Specialist Job OverviewThis position is responsible for defining project specifications for data management services.The successful candidate will understand external data collection, integration into clinical trials, and the necessary reconciliation processes to ensure accuracy and relevance.

  • Compliance Specialist

    12 hours ago

    Bellary, Karnataka, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000

    Compliance SpecialistThe role of a Compliance Specialist is crucial in ensuring that all business activities are carried out in accordance with regulatory requirements. We are seeking an experienced and detail-oriented professional to join our team as a Compliance Specialist.About the RoleAs a Compliance Specialist, you will be responsible for:Disseminating...

  • Clinical Operations Executive

    1 week ago

    Bellary, Karnataka, India beBeeClinical Full time ₹ 89,88,000 - ₹ 1,24,90,000

    Senior Clinical Operations ManagerJob Overview:Lead global unblinded CRA teams and provide technical support for unblinded clinical operations.Key Responsibilities:Implement effective recruitment strategies to meet project recruitment targets.Contribute to risk mitigation plans and manage clinical risks throughout the project lifecycle.Ensure clinical...

  • Healthcare Clinic Manager

    3 days ago

    Bellary, Karnataka, India beBeeClinical Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Healthcare Clinic ManagerThis is a leadership role where you will be responsible for overseeing the daily operations of our healthcare clinic.You will lead a team of medical professionals and support staff, ensuring that they are working together to provide high-quality patient care.Your goal will be to improve patient satisfaction, increase...

  • Clinical Data Insight Specialist

    13 hours ago

    Bellary, Karnataka, India beBeeData Full time ₹ 60,00,000 - ₹ 90,00,000

    Clinical Data Analyst RoleKey Responsibilities:Data listing and mappingCreating data visualizationsReviewing clinical data in JReviewAutomating tasksData extraction and transformation across multiple data sources at the study level as per specifications provided by data engineersCollaborating with internal/external stakeholders and data engineersDelivering...

  • Director of Clinical Trials Management

    1 day ago

    Bellary, Karnataka, India beBeeResearch Full time ₹ 1,00,00,000 - ₹ 1,70,00,000

    Senior Clinical Research Manager">The primary objective of the Senior Clinical Research Manager is to lead clinical trials and research studies from initiation to completion, ensuring timely delivery, regulatory compliance, and efficient team management.">Key Responsibilities:Initiate, plan, and manage complex clinical research projects from inception to...