Project Manager – Clinical Operations Hiring at Samahitha Research Solution

Project Manager – Clinical Operations Hiring at Samahitha Research Solution

Are you a professional with experience in clinical operations? Samahitha Research Solution, a renowned clinical research organization, seeks project managers and clinical operations to join their team in Bengaluru, Karnataka. This is an excellent opportunity for those with over two years of experience in clinical trial management and immediate availability.

Job Details

• Position: Project Manager – Clinical Operations
• Experience Required: Above 2 Years
• Location: Bengaluru, Karnataka
• Availability: Immediate Joiners Preferred

Key Responsibilities

As a Project Manager for Clinical Operations, you will be critical in managing clinical trials, ensuring regulatory compliance, and maintaining effective communication with stakeholders.

•  Obtains and maintains confidentiality of proprietary information belonging to Samahitha and the Sponsors, Investigator Sites, & Third Parties with which Samahitha contracts.
• Manages and oversees subcontractor activities in the assigned trial (represents Samahitha’s principal contact for subcontractors such as Clinical Laboratories, Translation Agencies, CRF and other document Printing Agencies, etc.)
• Development or customization of study documents (Study Management Plan and/or Monitoring Plan, Informed Consent, IMP Labels, Study Guidelines, Trial Specific Standard Forms, etc) in consultation with the Sponsor
• Management of translations for the assigned trials
• Manages the regulatory activities for the assigned clinical trial (compiles submission package that is sent to sites, verifies the accuracy and completeness of the submitted documents, informs the Regulatory Manager / Designee about all new / updated study documents that become available, and informs CRAs and CTAs each time a new approval is obtained).
• Plans investigator meetings and represents Samahitha during those meetings
• Adverse event reporting during the assigned clinical trial
• Management of clinical trial supplies (provides information regarding clinical drug supplies requirement for a particular trial (Quantity and Storage), and helps Depot Coordinator (Subcontractor) in arranging the infrastructure to meet those storage requirements; overall accountability of drugs sent/receipt to/from the sites, managed by their team of CRAs, maintains evidence of all CRF and other study materials received at Samahitha).
• Development and maintenance of the Trial Master File (administration of all study and centre-related documents before and during the study -i.e. drug accounting documents, correspondence, review the monitoring reports, contact reports and other organizational documents)
• Manage the site initiation, routine monitoring, and site closure visits (including planning, obtaining the green light from the Quality Assurance Manager / Designee, and reviewing monitoring reports).
• Coordinates and supports all CRAs and CTAs involved in the assigned clinical trial. Generates databases for appropriate study administration and administers all required study data to the database;
• Provides Sponsor or Samahitha Management Team with information on enrollment and local study management, if and when required and compiles and archives this study progress documentation.
• Management of Data Clarification Flow
• Prepares co-monitoring visits plan and conducts co-monitoring visits.
• Updates the investigator’s and team members’ informembers’ newsletters, phone conferences, etc.)

Qualifications and Skills

• Educational Requirements: Bachelor’s degree in a relevant field such as life sciences, pharmacy, or clinical research. Advanced degrees are a plus.
• Experience: Minimum of 2 years in clinical operations or a related field.

Prime Location

Located in Bengaluru, Karnataka

H2: How to Apply

Interested candidates are encouraged to apply by sending their updated resumes to career@samahitha.com. Priority will be given to immediate joiners.

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