Clinical Project Manager

2 days ago

Bengaluru India Biocon Biologics Full time

Job Description Job description: Clinical Project Manager 1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight. 2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation. 3. Supports preparation of regulatory dossier by providing documents and required information 4. Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable). 5. Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end. 6. Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws. 7. Monitors the quality of vendor deliverables, addresses quality issues with the appropriate team members and identifies opportunities to improve training, execution and quality control. 8. Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required. 9. Ensures study is at all times inspection ready. 10. Provides efficient updates on trial progress to Head of Clinical Operations and Senior Management. 11. Ensures trials are registered in trial registries (as applicable) and accuracy of trial information and that updates and final reporting are submitted on time. 12. Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting. 13. Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations/Senior Management. 14. Reviews and approves vendor invoices in collaboration with the Development Finance Specialist/Finance department personnel to ensure vendor payments occur in a timely manner 15. Supports vendor and site audits, follows up on audit findings to ensure appropriate responses and CAPAs implemented by vendors and sites. 16. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, guidance documents and regulatory requirements and provides oversight to the CRO team regarding TMF filing, maintenance and archival procedures. 17. Supports preparation of responses to queries from Regulatory, Marketing or any other molecule related queries. 18. Ensures at study end that eTMF is completed and archived, budget reconciled, lab samples and IMP samples retained or discarded as per internal decisions. 19. Supports SOP development and review, participates in internal process improvement activities and other activities as needed.

  • Clinical Data Manager 1

    2 weeks ago

    Bengaluru, Karnataka, India Emerald Clinical Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    At Emerald Clinical, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to...

  • Avance Clinical

    2 weeks ago

    Bengaluru, India Avance Clinical Full time

    Broad PurposeAvance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.Manager, Statistical Programming is responsible for the oversight of statistical programming operations and team, and for reporting to Associate Director, Statistical ...

  • Clinical Research Associate

    5 days ago

    Bengaluru, Karnataka, India, Karnataka MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdExperience: Minimum 3 yearsAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the...

  • Clinical Project Manager

    5 days ago

    Bengaluru, Karnataka, India, Karnataka Biocon Biologics Full time

    Job description: Clinical Project Manager 1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight. 2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation. 3. Supports...

  • Clinical Project Manager

    3 weeks ago

    Bengaluru, India Biobeam Scientific Instruments Full time

    Position: Clinical Project ManagerLocation: Bangalore (Hybrid)Type: Full-TimeExperience Required: 5+ YearsNotice Period: Immediate Joiners Preferred About the Role We are hiring a Clinical Project Manager to oversee projects in the areas of clinical diagnostics, medical instruments, and regulatory compliance. This role requires strong leadership,...

  • Clinical Project Manager

    2 days ago

    Bengaluru, Karnataka, India Biobeam Scientific Instruments Full time ₹ 15,00,000 per year

    Position: Clinical Project ManagerLocation: Bangalore (Hybrid)Type: Full-TimeExperience Required: 5+ YearsNotice Period: Immediate Joiners PreferredAbout the RoleWe are hiring a Clinical Project Manager to oversee projects in the areas of clinical diagnostics, medical instruments, and regulatory compliance. This role requires strong leadership,...

  • Clinical Aesthetic Therapist

    3 weeks ago

    Bengaluru, India Project Skin Full time

    About the Job Position: Clinical Aesthetic Therapist Location: Project Skin Dermatology & Aesthetic Clinic, HSR Layout, Bangalore Experience: Minimum 1-2 years Employment Type: Full-time Job Summary We are looking for a skilled and professional Clinical Aesthetician to join our team at Project Skin Dermatology & Aesthetic Clinic. The ideal candidate will...

  • Clinical Aesthetic Therapist

    2 weeks ago

    Bengaluru, Karnataka, India Project Skin Full time ₹ 2,00,000 - ₹ 6,00,000 per year

    About the JobPosition: Clinical Aesthetic TherapistLocation: Project Skin Dermatology & Aesthetic Clinic, HSR Layout, BangaloreExperience: Minimum 1-2 yearsEmployment Type: Full-timeJob SummaryWe are looking for a skilled and professional Clinical Aesthetician to join our team at Project Skin Dermatology & Aesthetic Clinic. The ideal candidate will have a...

  • Sr Clinical Programmer

    4 weeks ago

    India inVentiv Health Clinical SRE, LLC Full time

    Job DescriptionDescriptionSr Clinical Programmer (EDC Programming-Rave/Veeva)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 outcomes to address modern market realities.Our Clinical Development model brings the...

  • Clinical Programmer Ii

    5 days ago

    Bengaluru, India Syneos Health Clinical Full time

    **Description** **Clinical Programmer II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team,...