Remote Sr. Director, Clinical Data Management

FlexBoard; India; Remote; INR 17,192,000 - 22,923,000; Full time

Benefits offered by this job

Company bonus based on performance

Long‑term incentive compensation

Medical, dental and life insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Tuition reimbursement program

Job summary

FlexBoard seeks a Senior Director, Clinical Data Management to provide strategic leadership across the development program, ensuring data integrity and timely regulatory submissions.

Remote opportunity servicing the USA market; requires extensive experience in clinical data management, vendor governance, and cross-functional collaboration at senior levels.

Qualifications

• Bachelor's degree in life sciences or related field is required.
• Minimum 12 years in clinical development with hands-on data management experience.
• Strong understanding of FDA/ICH GCP guidelines and global studies.

Responsibilities

• Serve as senior partner to functional leaders for program planning and risk mitigation.
• Coordinate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and partners to identify data issues.
• Manage data management vendors including RFPs, budgets, and contracts.
• Oversee data review, cleaning, and database lock activities for analysis and submissions.
• Identify vendor risks and drive corrective actions to meet timelines and budgets.

Skills

Clinical Data Management

Vendor Management

Cross-functional Leadership

Regulatory Compliance

Data Analysis

Stakeholder Management

Education

Bachelor's degree in Life Sciences

Master's degree preferred

Job description

Note The job is a remote job and is reputed company to candidates in USA. reputed company, a reputed company company, is a clinical stage biopharmaceutical company reputed company on developing treatments for serious metabolic diseases. The Senior Director, Clinical Data Management provides strategic leadership and reputed company for reputed company clinical data management activities across the development program, ensuring data reputed company and supporting reputed company decision-making.

Responsibilities

• Serve as a senior thought partner to functional leaders, contributing to program-level planning, risk mitigation, and execution strategies
• Collaborate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and reputed company to identify and reputed company data-reputed company issues impacting timelines, reputed company, or compliance
• Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and reputed company
• reputed company database status with respect to key performance indicators, metrics, and program level deliverables and timelines to support program timelines
• reputed company data review, cleaning, and database lock activities to ensure accuracy and readiness for analysis and regulatory submission
• Proactively identify vendor risks, elevate issues as needed, and reputed company reputed company-cause analysis and corrective actions
• Balance reputed company, timelines, and cost while driving pragmatic solutions reputed company with program priorities
• Foster a culture of accountability, collaboration, and reputed company improvement across internal teams and reputed company partners
• reputed company reputed company supervision and periodic review of work for departmental employees, to ensure reputed company and execution of clinical development timelines
• reputed company and mentor reputed company of data management professionals
• Foster a reputed company environment that encourages innovation and knowledge sharing
• Ensure effective resource allocation and management across research departments
• reputed company performance and accountability through reputed company communication of expectations and goals
• Support organizational reputed company by scaling data management capabilities and processes as the portfolio evolves
• Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is reputed company on those priorities, and they understand their level of accountability for results and the measurement process
• Manage the application and communication of reputed company company policies and procedures

Skills

• Bachelor's degree required
• Minimum of 12 years of experience in clinical development reputed company the pharmaceutical or biotechnology industry, including significant experience as a hands-on clinical data management reputed company
• Strong understanding of drug development, FDA regulations, and ICH GCP guidelines, with thorough knowledge of the pharmaceutical industry and the conduct of global clinical studies
• Demonstrated leadership and people-management experience, with a proven reputed company record of leading cross-functional and international teams and influencing senior leaders across functions
• Experience managing clinical data management vendors, contractors, and service providers to ensure delivery of program objectives and timelines
• Strong analytical skills with demonstrated experience gathering, interpreting, and analyzing clinical research and drug development data to support decision-making and risk management
• Excellent communication, presentation, and stakeholder-management skills, with the ability to translate reputed company data and risks into reputed company, business-relevant insights
• Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies required
• Master's degree in Life Sciences or a reputed company discipline highly preferred
• At least four years of management experience reputed company pharmaceutical development is preferred

Benefits

• Company bonus based on individual and company performance
• Long-term incentive compensation depending on the position's level or other company factors
• Medical, dental and reputed company coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group reputed company, critical illness, identity theft protection, pet insurance and auto/home insurance