Samahitha is seeking an experienced Project Manager to join their team in Bengaluru, Karnataka. The successful candidate will be responsible for managing clinical trials, overseeing subcontractor activities, and ensuring compliance with regulatory requirements.
💼About the Role
As a Project Manager, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibilities will include:
Confidentiality: Maintaining confidentiality of proprietary information belonging to Samahitha, sponsors, investigator sites, and third parties.
Subcontractor Management: Managing and overseeing subcontractor activities, including clinical laboratories, translation agencies, and printing agencies.
Study Document Development: Developing and customising study documents, including study management plans, informed consent forms, and trial-specific standard forms.
Regulatory Activities: Managing regulatory activities, including compiling submission packages, verifying the accuracy and completeness of documents, and informing regulatory managers and CRAs about new or updated study documents.
Investigator Meetings: Planning and representing Samahitha during investigator meetings.
Adverse Event Reporting: Ensuring adverse event reporting during the assigned clinical trial.
Clinical Trial Supply Management: Managing clinical trial supplies, including providing information on drug supply requirements and maintaining evidence of all CRF and study materials received.
🎯Requirements
Experience: Above 3+ years of experience in clinical research.
Clinical Operations Knowledge: Strong understanding of clinical operations, including good clinical practice (GCP) and regulatory requirements.
Skills:
Excellent communication and project management skills.
Ability to work independently and prioritise tasks effectively.
Strong attention to detail and organisational skills.
🎁What We Offer
Career Growth: Opportunities for professional development and growth in a leading clinical research organisation.
Collaborative Environment: A dynamic and supportive team environment.
Competitive Benefits: Competitive salary and benefits package.
🌐Why Choose Samahitha?
Industry Leader: Opportunity to work with a leading clinical research organisation.
Professional Development: Opportunities for professional growth and development.
Innovative Culture: A company that values innovation, quality, and people.
If you’re interested in this exciting opportunity, please drop your resume at career@samahitha.com.