Job Description

Job Details
Position : AM/ Manager- Clinical Research Job Location : Anand, Gujarat
About the company : One of the leading names in the Pharmaceutical Domain
Job Requirement :

• MBBS/ BDS/ BAMS/MD (Ayurveda/ Pharmacology/Medicine)/ PhD (Pharmacology/Clinical Pharmacy/Biotechnology) with 8+ Years of experience in Clinical Research from Herbal/ Nutraceutical/ Similar Industries.

Job Role :

• Assist to create a concept for Clinical Research and Intellectual Property Rights Department (CR) at PHPL.
• Draft CR policies and procedures.
• Responsible for managing the planning, implementation, and administration of clinical and preclinical projects; maintaining an overview of ongoing clinical, preclinical and in vitro studies.
• Responsible for preparing protocol, PIS, consent, CRF and investigators brochure for IEC submission and amendments.
• Responsible for conceptualization of clinical research.
• Responsible for managing supply of investigational product to trial site.
• Responsible for monitoring of outsourced research studies to ensure progress of research projects is in accordance with protocol and applied regulatory guidelines/requirements.
• Responsible for identifying, evaluating, and rectifying problems to ensure trial progress smoothly.
• Responsible for providing training to research scientists/associates involved in clinical research.
• Responsible for statistical analysis of data generated through trials to prepare final report in collaboration with trial investigator.
• Responsible for collaboration with investigator and other coinvestigators to write manuscript and publish it in reputed scientific journals.
• Responsible for planning meetings with teams involved in the clinical trials.
• Responsible for understanding the requirements of the various regulatory/controlling bodies, agencies and guiding the project in conforming to those requirements.
• Responsible for assisting in regulatory filing, such as phyto-pharmaceutical filing, FDA/FSSAI filing.
• Responsible for creation and maintenance of all clinical research files.
• Responsible for managing the patent drafting and filing to Indian Patent office as well as other patent offices (WPO/USPTO/PCT).
• Responsible for managing Trademark filing.
• Responsible for drafting, developing, and reviewing company policies related to clinical research, IPR and publication.

• Any other responsibility, if assigned by Management establishing and reviewing below site CR lab processes and methods with the support of project team and functional head, based on the relevant Indian/global regulations/standards and company policies/standards.
• Managing the CR lab to assure the EHS compliance, Maintain safe and healthy working conditions for employees under his/her supervision. Promote EHS awareness to subordinates and ensure that employees who report to him/her attend required training. Instruct employees under his/her supervision in with all safety rules and practices.
• Develop high-performance atmosphere.
• Contribute and influence strategic direction for leadership using informal and formal communication. Check mail/communications regularly for updating.
• Coordinate all cross-functional activities, represent customers internally and collaborate with leaders in varied areas on allocation across projects and resource planning.
• Ensure to exercise decision-making and independent judgment while being aligned with customers and management.
• Any other responsibility, if assigned by DIC and management.

Contact Person : Sarita Chaudhary Email : sarita@namanstaffing.com
Interested candidates can directly APPLY on the below link