Clinical Research Manager
9 - 12 Years of Experience
6.00L - 8.00L Per Annum
Full TimeAizant Drug Research Solutions Pvt. Ltd.
Hyderabad, Telangana, India
Posted on 24-04-2023
743 Views
5 Vacancies
Description
- Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
- Liaising with doctors/consultants or investigators on conducting the trial.
- Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. Training the study staff in standard operating procedure for the clinical trials as per applicable regulatory requirements.
- Verify that investigator and investigator’s team are adequately trained and comply with the protocol.
- Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.
- Monitoring the trial throughout specified duration involving monitoring visit to the trial sites.
- Source data verification.
- Informed consent form review, case report form review, investigational drug accountability, and adverse event review.
- Ensuring all unused trial supplies are accounted for at all sites.
- Writing visit reports, filing and collecting trial documentation and reports.
Category
R&D / F&D / ADL / Pharma Research
Preferred Education
About Organization
Aizant® is an integrated drug development solutions provider. Aizant was established by experienced pharmaceutical professionals with global exposure. We are a rapidly growing contract research organization (CRO) with a diverse portfolio of capabilities partnering with health care companies specializing in new molecular entities (NME’s), generics (ANDA’s) and over the counter (OTC’s) products globally. We offer comprehensive solutions for preformulation, formulation development of conventional and novel drug delivery products, analytical development, cGMP Scale-up, niche commercial manufacturing, stability, bioavailability, bioequivalence, bioanalysis, pharmacokinetics, biostatistics and clinical diagnostics. We add exponential value to our clients R&D programs at every stage of drug development right from the discovery of the molecule to commercialization and subsequent life cycle management. We are the vital link between the pharmaceutical companies and the healthcare industry.
Contact Info
Address:
S.No: 172 & 173, Apparel Park road, Dulapally, Quthbullapur Mandal, Medchal District, Hyderabad, Telanagana-500100.