Manager Clinical Data Management

Project Role: Manager, Clinical Data Management

Work Experience: 5+ Years

Work location: Kolkata

Work Mode: Hybrid

Essential Functions

• Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses.

• Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the teams utilization rates; the direct reports training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives.

• Develop and implement plans for measuring and improving employee engagement, ensuring global consistency.

• Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable.

• Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership.

• Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover.

• Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested.

• Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support.

Qualifications

• Bachelors Degree Clinical, biological or mathematical sciences or related field, or nursing qualification Req

• 10-15 years of relevant work experience including people management. Equivalent combination of education, training and experience.

• Advanced knowledge of Data Management processes and systems.

• Solid understanding of clinical drug development process and production of Data Management deliverables

• Strong organizational skills, metrics calculations, and time management skills.

• Strong verbal/written communication skills.

• Ability to work on multiple projects and manage competing priorities effectively

• Effective mentoring and developed coaching skills.

• Ability to achieve results through proactive communication and facilitation in a matrix service delivery environment with shared accountabilities.

• Sound judgment, decision-making and problem-solving skills.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

• Ability to follow instructions/guidelines, utilize initiative and work independently.

• Understanding on basic Project Finance (EAC, forecasting, burn-rate monitoring and recognizing & pursuing OOS where appropriate)

• Ability to drive business and financial results – short and long term.

• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with direct reports, colleagues, and customers.

• Demonstrates good judgement in requesting input from senior staff. When requesting input, ensure clearly laying out the issue and required background details, articulating what support is needed; and what are the recommended actions.