Clinical Project Manager
3 weeks ago
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.
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Clinical Research Data Analyst
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amravati, India beBeeDataAnalyst Full timeLead Data Analyst - Clinical ResearchWe are seeking a highly skilled Lead Data Analyst to join our team in clinical research. This is an exciting opportunity for someone who has expertise in data analysis, statistical programming, and project management.This role involves managing and executing data analyses for clinical trials using SDTM and CDISC...
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Clinical Documentation Expert
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amravati, India beBeeRegulatory Full timeRegulatory Document SpecialistWe are seeking a skilled Regulatory Document Specialist to support our medical device projects.Create, update, and manage clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs)Conduct...
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Senior Clinical Specialist
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amravati, India beBeeNeurologist Full timeOur organization seeks an experienced Neurologist to provide high-quality patient care and contribute to our multidisciplinary team. Job DescriptionThe ideal candidate will be responsible for conducting comprehensive neurological assessments, diagnoses, and management plans for adult patients with various conditions. This includes diagnosing and managing...
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Senior Data Analyst
3 days ago
amravati, India beBeeStatistical Full timeStatistical Programmer RoleThis is a challenging and rewarding role that involves working with data manipulation, analysis, and reporting of clinical trial data.The successful candidate will have advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM).Key Responsibilities:Performing data manipulation, analysis and reporting of...
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Project Manager
1 week ago
Amravati, India Trikon Group Full timeExperience: Minimum 5 years (with Sales background) Shift Timing: 01:30 PM to 10:30 PM (UK Shift) Location: Ahmedabad Salary Range: ₹55,000 – ₹65,000 per month Job Type: Full-Time Role DescriptionThis is a full-time on-site role for a Project Manager, located in Ahmedabad. The Project Manager will oversee and coordinate project activities, ensuring...
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Project Manager
2 weeks ago
Amravati, India Trikon Group Full timeExperience: Minimum 5 years (with Sales background) Shift Timing: 01:30 PM to 10:30 PM (UK Shift) Location: Ahmedabad Salary Range: ₹55,000 – ₹65,000 per month Job Type: Full-Time Role DescriptionThis is a full-time on-site role for a Project Manager, located in Ahmedabad. The Project Manager will oversee and coordinate project activities, ensuring...
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Project Manager
4 days ago
amravati, India Hello Energy Full timeProject Manager – Client & Utility data connections onboardingDepartment: Data Services Location: RemoteJob SummaryWe are looking for a Project Manager who can coordinate and deliver multiple small-to-medium projects simultaneously, each representing a client's building or portfolio. Every project involves different data collection methods, regional...
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Project Manager
3 weeks ago
Amravati, India Publicis Production Full time· JOB DESCRIPTION Working in an international environment and global Clients· Independent management of the projects;· Supervision over all phases of the project implementation (design, testing, implementation and support);· Cooperation with the internal departments of strategy, creation, and technology;· Preparation of project documentation (cost...
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SAP Project Manager
5 days ago
Amravati, India ITC Infotech Full timeDear Candidate,ITC Infotech is a leading global technology services and solutions provider, led by Business and Technology Consulting. ITC Infotech provides business-friendly solutions to help clients succeed and be future-ready, by seamlessly bringing together digital expertise, strong industry specific alliances and the unique ability to leverage deep...
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SAP Project Manager
6 days ago
Amravati, India ITC Infotech Full timeDear Candidate,ITC Infotech is a leading global technology services and solutions provider, led by Business and Technology Consulting. ITC Infotech provides business-friendly solutions to help clients succeed and be future-ready, by seamlessly bringing together digital expertise, strong industry specific alliances and the unique ability to leverage deep...
