Talent.com
This job offer is not available in your country.
Clinical Project Manager [Urgent]

Clinical Project Manager [Urgent]

Biocon BiologicsIndia
1 day ago
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.

Create a job alert for this search

Project Manager • India

Related jobs
  • Promoted
  • New!
Medical Revenue Cycle Manager

Medical Revenue Cycle Manager

beBeeBillingNagpur, Maharashtra, India
The Medical Billing Specialist will oversee the processing of medical claims, ensuring compliance with payer guidelines and regulations. They will review billing discrepancies, address rejections an...Show moreLast updated: 15 hours ago
  • Promoted
Subject Matter Expert (Medical) - 47545

Subject Matter Expert (Medical) - 47545

TuringNagpur, IN
Based in San Francisco, California, Turing is the world’s leading.AI labs and a trusted partner for global enterprises deploying advanced AI systems. Turing supports customers in two ways : first, by...Show moreLast updated: 9 days ago
  • Promoted
Clinical Project Manager

Clinical Project Manager

Biocon BiologicsIndia
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.Leads selection of CR...Show moreLast updated: 21 days ago
  • Promoted
  • New!
Healthcare Innovator

Healthcare Innovator

beBeeInnovatorNagpur, Maharashtra, India
We are on a mission to revolutionize the way we approach healthcare, focusing on evidence-backed practices and time-tested methods. At Amura, you will have the autonomy to manage 150+ patients from ...Show moreLast updated: 16 hours ago
  • Promoted
Deputy General Manager- Medical Affairs (GI)

Deputy General Manager- Medical Affairs (GI)

ViatrisNagpur, IN
Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes.Formed in ...Show moreLast updated: 19 days ago
  • Promoted
Full Stack Developer Nest.js and Angular- Healthcare

Full Stack Developer Nest.js and Angular- Healthcare

BigRionagpur, maharashtra, in
Full-Time | UK Shift (1 : 00 PM – 10 : 00 PM IST approx.Technology / Software Development.BigRio is a US-based technology consulting firm delivering cutting-edge software solutions across industries in...Show moreLast updated: 7 days ago
  • Promoted
Medical Affairs Executive

Medical Affairs Executive

Panacea BiotecIndia
Job Description Medical Expertise and Support : Medical training for Sales Force for Pharma, vaccines & Nutrition Provide expert medical and scientific input to internal and external stakeholders.St...Show moreLast updated: 22 days ago
  • Promoted
Lead Clinical Operations (MBBS - Cardiac) JIS113379

Lead Clinical Operations (MBBS - Cardiac) JIS113379

Krayr SolutionsIndia
Opening Lead Clinical Operations (Cardiac - MBBS) for a Digital Health Company based in Mumbai.Position : Lead Clinical Operations. Oversee and manage clinical operations of the cardiac rehabilitatio...Show moreLast updated: 21 days ago
  • Promoted
Medical Doctor

Medical Doctor

Tricog HealthNagpur, IN
Consultant Physician / Non-invasive Cardiologist.MBBS+ MD[General Medicine / Internal Medicine].Experience : 5+ years post MBBS. Strong knowledge of ECG interpretation and experience working in cardiolo...Show moreLast updated: 30+ days ago
  • Promoted
Manager - Health Claims - Noida ( Only Medicos )

Manager - Health Claims - Noida ( Only Medicos )

TATA AIG General Insurance Company LimitedIndia
Medicos Only - BAMS and BHMS - FRESHERS CAN ALSO APPLY Tata AIG General Insurance Company Limited is a joint venture between Tata Group and American International Group (AIG).Since its set-up in 20...Show moreLast updated: 8 days ago
  • Promoted
Medical Doctor

Medical Doctor

Amura HealthNagpur, IN
But deep down, you've always known.More truth, happiness, beauty and meaning to the way we live and care.The truth is that science has always been there. But healthcare never touched it as it is ove...Show moreLast updated: 14 days ago
  • Promoted
Novartis Healthcare - Territory Business Executive

Novartis Healthcare - Territory Business Executive

Novartis Healthcare Pvt. Ltd., India
The Sales Representative is a leading driver of our customer interactions and sales performance.They are the face of our customer experience approach and build deep relationships that deliver value...Show moreLast updated: 30+ days ago
  • Promoted
Medical Affairs Manager

Medical Affairs Manager

Panacea BiotecIndia
Experience : 5–7 years for Manager Qualification : MBBS / MD (Pharmacology, Pediatrics, Medicine) OR M.Pharm / PhD (Pharmacology, Life Sciences). Role Overview At Panacea Biotec, the Medical Affairs p...Show moreLast updated: 21 days ago
  • Promoted
Senior Clinical Data Associate

Senior Clinical Data Associate

Precision For MedicineIndia
Position Summary The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Only 24h Left! Medical Administrator

Only 24h Left! Medical Administrator

Kauvery HospitalIndia
Kauvery Hospital – erstwhile KMC Specialty Hospital, is located at the heart of Trichy City.KMC acquired Seahorse Hospital – a public limited company in the year 2008 & since then it has been funct...Show moreLast updated: 1 hour ago
  • Promoted
Medical Affairs Manager

Medical Affairs Manager

Ajanta Pharma LtdIndia
Job Title : Manager - Medical Affairs.We are seeking a passionate and experienced Medical Affairs Manager to join our dynamic team. In this strategic role, you will be the scientific bridge between t...Show moreLast updated: 22 days ago
  • Promoted
Medical Affairs Manager

Medical Affairs Manager

Ipca Laboratories LimitedIndia
Asst Manager / Manager – Medicoregulatory Affairs Department.Medicoregulatory Affairs Job location : .Responsibilities I To independently review following applications online through Sugam Portal to C...Show moreLast updated: 30+ days ago
  • Promoted
Medical Administrator

Medical Administrator

Kauvery HospitalIndia
Kauvery Hospital – erstwhile KMC Specialty Hospital, is located at the heart of Trichy City.KMC acquired Seahorse Hospital – a public limited company in the year 2008 & since then it has been funct...Show moreLast updated: 20 days ago
  • Promoted
Liferay Team Lead

Liferay Team Lead

Huptech HR SolutionsIndia
Location : - Ahmedabad (Work from Office).Develop, test, and deploy web applications using the Liferay DXP platform.Collaborate with cross-functional teams to gather business requirements and transl...Show moreLast updated: 19 days ago
  • Promoted
Medical Consultant

Medical Consultant

XpertDoxIndia
What we can offer you We are looking for a Physician Consultant to join our team at XpertDox (www.XpertDox uses advanced data analytics and proprietary natural language processing (NLP) to structur...Show moreLast updated: 30+ days ago