We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Mehsana (India), Toronto (Canada), Warsaw (Poland), London (UK) and the USA with approximate 750 employees located in our facilities across the globe.
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Lambda offers full-spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain is executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality in order to help clients develop products safely, effectively, and quickly.
Delivering the best is accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That’s why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.
Position: Project Manager – Clinical Trials
Location: Ahmedabad, Gujarat
Roles and Responsibilities
- Ensure project coordination and conduct as per protocol and SOPs
- Work in close coordination with the Principal Investigator and Head-CPMA
- Review and finalization of protocol, ICF, CRF, and other appendices (applicable in case of special studies)
- Communicate with the sponsor on all projects related issues.
- Distribute protocol and related documents.
- Handle project-related IP and its documentation (IP retrieval, verification, accountability, dispensing, etc).
- Issuance of SOP related forms
- Prepare labels and Binders (binder, files, dispensing labels etc).
- Verification of Randomization schedule
- Train the study personnel on project-related activities and hand over relevant documents to the concerned person.
- Ensure the arrangement of staff and other study-related activities.
- Ensure proper initiation and conduct of the trial.
- Communicate with sponsors, other departments, and team on appropriate aspects of the clinical studies
- Ensure proper documentation of Adverse Drug Reactions, Note to files, Deviations etc.
- Reporting of SAEs as per regulatory requirements
- Accountability of ICF and Criteria checks
- Check all forms including consent forms.
- Ensure arrangement for activities like ambulatory, precheck-in visits, post-study, and co-ordination of the same.
- Co-ordinate QA audits of corrected forms.
- Ensure subject contact during the washout period and follow-ups
- Handle subject compensation.
- Check all the forms
- Generate protocol deviations
- Send clinical updates to all concerned.
- Send communications of discontinued subjects, BA details to concern.
- Take part in the day-to-day clinic activities
- Help maintain and update all the systems and SOPs in the department
- Train the staff on the entire Project-related aspects and related SOPs & giving inputs for developing systems.
Experience: 2-7 Years
Salary: 3,00,000 to 6,00,000 INR (CTC/PA), Medical Insurance – Self + 3 Family members
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