04 Aug
|
Premier Consultants
|
Maharashtra
04 Aug
Premier Consultants
Maharashtra
Job Title: Manager Lab Centralized Monitoring
Location: Thane, Maharashtra (Hybrid – 2 to 3 days work from office)
Experience: 10+ Years
Education: Bachelor's or Master's Degree in Life Sciences (Ph.D. not preferred)
Job Summary
We are seeking an experienced and dynamic Manager – Lab Centralized Monitoring to lead a team of Centralized Monitoring Project Coordinators (CPCs). The ideal candidate will have a solid clinical research background, proven people management experience, and expertise in centralized monitoring operations within a CRO or clinical research environment. This role requires strong leadership capabilities, operational oversight, quality management, and stakeholder engagement to ensure successful delivery of centralized monitoring activities.
Key Responsibilities
Team Leadership & People Management
- Lead, mentor, and manage a team of 15+ Centralized Monitoring Project Coordinators (CPCs).
- Drive employee engagement, performance management, coaching, and career development initiatives.
- Conduct performance reviews, provide regular feedback, and support succession planning.
- Manage employee relations, resolve team concerns, and ensure adherence to organizational policies.
- Participate in hiring, onboarding, training, and retention of high-performing talent.
Operational Management
- Plan, assign, and oversee centralized monitoring activities across multiple studies and projects.
- Ensure efficient resource allocation and workload management.
- Track team productivity, quality metrics, and operational performance.
- Collaborate with global project teams and cross-functional stakeholders to ensure consistent service delivery and study execution.
- Support study assignments aligned with employee experience and training.
Quality & Compliance
- Ensure compliance with GCP, ICH guidelines, SOPs, and applicable regulatory requirements.
- Conduct regular quality reviews and mini-audits of team deliverables.
- Lead investigations related to quality incidents, perform root cause analysis, and implement CAPA plans.
- Identify operational risks and implement corrective and preventive actions.
- Support audit readiness and continuous quality improvement initiatives.
Training & Development
- Ensure team members receive required training, system access, and development opportunities.
- Oversee training plans, SOP reviews, and mentored learning programs.
- Promote a culture of continuous learning and operational excellence.
Stakeholder Management
- Build strong relationships with internal stakeholders, global teams, and project leadership.
- Communicate business priorities, project updates, risks, and performance metrics effectively.
- Support departmental initiatives focused on quality, productivity, and process improvements.
Required Skills & Competencies
- Strong people management and leadership experience.
- Expertise in Clinical Research, Centralized Monitoring, and Clinical Operations.
- In-depth knowledge of GCP, ICH Guidelines, and regulatory requirements.
- Strong quality management, CAPA, and root cause analysis skills.
- Excellent communication, presentation, and stakeholder management abilities.
- Strong analytical, organizational, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in MS Office and clinical research systems/tools.
Preferred Background
- Experience working with a mid-sized or large CRO.
- Proven experience managing teams of 15 or more direct reports.
- Exposure to global clinical research projects and cross-functional collaboration.
Qualification
- Bachelor's or Master's Degree in Life Sciences.
- 10+ years of relevant Clinical Research experience.
- Minimum 5+ years of direct people management experience.
Employment Type
Full-Time
Work Model
Hybrid (Work from Office 2–3 days per week)
📌 Manager-Lab Cent Monitoring (Maharashtra)
🏢 Premier Consultants
📍 Maharashtra