Senior Manager - Clinical Data Management

Thermo Fisher Scientific India Pvt Ltd; Bengaluru; Hybrid; INR 3,000,000 - 6,000,000; Full time

Job summary

Thermo Fisher Scientific India Pvt Ltd in Bengaluru seeks a Senior Manager, Clinical Data Management, to lead a portfolio within the FSP model. You will manage a small team of project staff, mentor, and work with senior management on training and process improvements.

The role requires 10+ years in CDM and 5+ years in leadership, with hands-on experience in workflow allocation, dashboards, and regulatory compliance. Travel domestically and internationally may be required.

Qualifications

• 10+ years of experience in Clinical Data Management in End-to-End Cycle.
• 5+ years of leadership responsibility in current or previous roles.
• Hands-on experience in Workflow Allocation, Line Management, Performance Management, Quality/CAPA, Reports, Dashboards, Stakeholder Management.
• Experience in FSP Business model preferred.
• Equivalency consisting of education, training and/or related experience may be considered.

Responsibilities

• Manages staff, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
• Approves courses of action on salary administration, hiring, corrective action, and terminations.
• Reviews and approves time records, expense reports, requests for leave, and overtime.
• Provides support, oversight and coaching to the portfolio team to ensure tasks are completed accurately, on time and within budget.
• Manages resourcing for all assigned staff, including global reporting and strategy with senior management.
• Ensures staff compliance with documented procedures.
• Assists with implementation of operational activities of study or portfolios with focus on quality to support study manager.
• Participates in development and implementation of processes, procedures and training for the data management function.

Skills

Leadership

Project management

Regulatory compliance

Communication

Confidentiality

Team management

Education

Bachelor's degree in Life Science

Job description

Senior Manager, CDM - FSP Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Manager Clinical Data Management – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to manage a small team of project staff and the workload of direct reports. As a Manager Clinical Data Management , you'll collaborate with senior management for training, mentoring, and guiding project staff and direct reports.

What You’ll Do:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
• Approves courses of action on salary administration, hiring, corrective action, and terminations.
• Reviews and approves time records, expense reports, requests for leave, and overtime.
• Provides support, oversight and coaching to the portfolio team to ensure that all tasks are completed accurately, on time and within budget to meet or exceed client expectations.
• Manages resourcing (allocations) for all assigned staff, includes global resourcing reporting and strategizing with senior management.
• Ensures staff compliance with documented procedures.
• Assists with implementation of operational activities of study or portfolios, with focus on quality in order to better support study manager.
• Participates in the development and implementation of processes, procedures and training for the data management function.

Education and Experience Requirements:

Bachelor's degree in Life Science is Preferred 10+ Years of experience in Clinical Data Management in End to End Cycle 5+ year of leadership responsibility in current or previous roles. Should have hands on experience in Workflow Allocation, Line Management, Performance Management, Quality/CAPA, Reports, Dashboards, Stakeholder Management, Having experience in FSP Business model is preferred In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Ability to effectively apply knowledge and skills in an organized fashion while adhering to regulatory guidelines, SOPs and client expectations
• Good attention to detail and skill with numbers
• Good written and verbal communication skills with good command of English language and grammar
• Good analytical/problem-solving skills
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Good interpersonal skills
• Ability to act as a study expert for DM processes
• Ability to effectively manage and motivate others and to effectively supervise and delegate tasks
• Ability to set and meet, for self and team, timelines or be able to recognize and schedule changes inresponse to project demands

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Experience Level Senior Level