14 Oct
|
Althera Laboratories India, Bangalore
|
Bengaluru
14 Oct
Althera Laboratories India, Bangalore
Bengaluru
We are looking for an experienced Project Management professional with 7 to 8 years of relevant experience in Bioanalytical Studies, Bioequivalence (BE) Studies, and Clinical Trial Phases. The ideal candidate should have prior experience working with a Clinical Research Organization (CRO) and hands-on exposure to the monitoring of bioequivalence studies and clinical trials.
Key Responsibilities
- Plan, coordinate, and monitor bioanalytical studies, bioequivalence studies, and clinical trial activities.
- Manage project timelines, deliverables, resources and study milestones.
- Participate in the monitoring of bioequivalence studies and clinical trials to ensure compliance with approved protocols, SOPs, and applicable regulatory requirements.
- Coordinate with clinical operations, bioanalytical laboratories, medical teams, sponsors, and other stakeholders.
- Track study progress, identify project risks, resolve operational challenges, and ensure timely completion of deliverables.
- Ensure adherence to applicable GCP, GLP, ethical standards, and regulatory guidelines as relevant to the studies.
- Maintain accurate study documentation, progress reports, and project-related records.
- Support audits, inspections and quality compliance activities related to clinical and bioequivalence studies.
Required Qualifications & Experience
- 7 - 8 years of relevant experience in clinical research, project management or study coordination within a Clinical Research Organization (CRO).
- Practical experience in bioanalytical and bioequivalence studies and clinical trial phases.
- Demonstrated participation in the monitoring of bioequivalence studies and clinical trials.
- Strong understanding of clinical study protocols, GCP principles, study documentation and regulatory compliance.
- Excellent project coordination, stakeholder management, communication, and problem-solving skills.
- Ability to manage multiple projects and meet defined timelines and quality standards.
Preferred Candidate Profile
Candidates with hands-on CRO experience, solid project execution capabilities, and practical exposure to the monitoring of clinical trials and bioequivalence studies will be preferred.
Role: Other Program / Project Management - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Project & Program Management, Employment Type: Full Time, Permanent Role Category: Other Program / Project Management Education UG: B.Pharma in Any Specialization PG: M.Pharma in Any Specialization Key Skills Skills highlighted with ‘‘ are preferred keyskills BioequivalenceClinical ResearchProject ManagementBioanalyticalClinical Trials GCPGLP
📌 Project Management Clinical Research & Bioequivalence Studies (Bengaluru)
🏢 Althera Laboratories India, Bangalore
📍 Bengaluru