hireejobs
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Clinical Research Manager-Medical Devices

10.00 to 16.00 Years   Delhi   25 Sep, 2020
Job LocationDelhi
EducationNot Mentioned
SalaryRs 6 - 9 Lakh/Yr
IndustryIT - Software
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Designation: Clinical Research Manager Reports to: DirectorIndustry: Medical Devices (Class II & Class III Orthopedic Implants)Place of Posting: Sonepat 2 KM from NCR Delhi Border (Singhu Border)Working Hours: 9:30 AM to 6:00 PM (Monday to Saturday)Job Responsibilities & Duties

  • To oversee global & local clinical projects, ensuring their execution in a timely and effective manner within budget and complying with regulatory requirements.
  • To lead- Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs).
  • To lead the clinical trial projects, administer & track tasks performed by clinical research associates, CTAs for their timely and effective execution for local clinical trials.
  • To review and prepare key regulatory documents ensuring it complies with requirements.
  • Development & implementation of clinical process procedures, programming additional clinical research.
  • Create & oversee trial Budget.
  • Meeting with principal investigation onsite & remotely.
  • To Co-monitor the visits with the clinical research associate for the quality execution of clinical trials, quality audits and inspection issues.
  • To collaborate with the Clinical Operation Head coordinate country level protocol feasibility, identification of potential sites, coordinating site assessments and elect appropriate sites and site initiations to allocate local clinical trials.
  • To take responsibility for effective site recruitment, providing the necessary criteria for the successful staffing. Networking with institutions and academicians in identifying good centres for clinical trials.
  • To define clinical research associates, CTAs and PMs individual development plan, provide them with new challenges and/or responsibilities in alignment with business needs.
  • To provide trial related communication and insight to key internal and external stakeholders, maintain ongoing communication with the Ethics Committees and the Health Authority ensuring the central and local Ethic committee is provided with the documents.
  • To support the Regulatory & quality team in internal & external audits whenever required.
  • Other duties as assigned by H.O.D.
Key Skills:USFDA, Clinical research, good clinical practices, Medical Devices, Dossier, CER, Ethics committee, clinical trials, SAS, protocol designing, ISO 13485, ISO 14971, MDSAP, EU MDR, 510k submissions, Orthopaedic, Medical Device Directive, PMS, DCGI, Adverse events.Required Candidate profileDesired Education, Experience, Skills & Competencies:
  • Bachelor s/Master s Degree/PhD in clinical research with 10+ Year experience in Clinical Research in Medical Devices Industry preferably (Class II & Class III Orthopaedic Implants).
  • Knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, DCGI, Medical Device Directive (MDD), EU MDR, USFDA & MDSAP guidelines & Good Clinical Practices).
  • Must have knowledge of SOPs, GCPs, FDA Regulations, Investigation Protocol, PMS, CER, Adverse Events & SAE, Clinical trial budgeting, scientific & medical writing knowledge.
  • Highly organized with excellent attention to detail.
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
  • Strong ability to multi-task and to meet business deadlines.
Key Skills:USFDA, Clinical research, good clinical practices, Medical Devices, Dossier, CER, Ethics committee, clinical trials, SAS, protocol designing, ISO 13485, ISO 14971, MDSAP, EU MDR, 510k submissions, Orthopaedic, Medical Device Directive, PMS, DCGI, Adverse events. ,

Keyskills :
adverse eventsbudgetingacer hardwaresafetymedical writingclinical research associatesiso 14971protocol designingclinical researchcroexternal auditmedical device directiveclinical trialsqualityindividual developmentmedical devicesclinical p

Clinical Research Manager-Medical Devices Related Jobs

© 2019 Hireejobs All Rights Reserved