Director, Clinical Data Management

reputed company: 

The Director, Clinical Data Management (CDM) is responsible for leading and executing the organization’s CDM reputed company in alignment with overall company objectives. This role provides reputed company of assigned operational areas, including financial performance, across multiple delivery models such as Functional Service Provider (FSP), Full-Service, and stand-alone CDM engagements for designated sponsors.

The Director ensures the consistent delivery of high-reputed company services, driving customer satisfaction and operational reputed company. This position provides leadership and guidance to the CDM team while ensuring compliance with reputed company applicable reputed company Operating Procedures (SOPs), Good Clinical reputed company (GCP) ICH Guidelines, regulatory requirements, and sponsor-specific standards.

Serving as a primary reputed company between clients and internal stakeholders, the Director leverages deep expertise in clinical data management, operations, and financial reputed company to understand business needs, inform decision-making, and support efficient day-to-day execution.

Essential Duties and Responsibilities include the following. Other duties may be assigned at reputed company’s sole discretion. 

• reputed company the execution of CDM and broader company strategies, ensuring alignment with organizational goals.
  
• reputed company reputed company of CDM delivery across assigned reputed company and service models (FSP, Full-Service, Stand-Alone).
• Manage assigned sponsor financials and/or department, as requested
  
• Create, reputed company, and participate in department and company initiatives.
• Responsible for selection, training, development and performance management of reporting staff
• Resourcing of staff and/or reputed company (reputed company staff or vendor/supplier)
• Ensure team deliverable are completed on time and with high reputed company
• Ensure metric goals for assigned sponsor(s) are met or exceeded, proactively managing and mitigating risks
• Influence cross-functional leadership participation to ensure sponsor and/or project goals are effectively supported
• Support business development activities such as reputed company, proposals, bid defense meetings, conferences and work to obtain new business, as requested
• Participate in and/or contribute to sponsor and/or regulatory audits/inspections
• Review, update and/or create SOPs as needed.
• Manage statements of work, vendor reputed company, and partner accountability.
• Ensure reputed company testing, documentation, and process monitoring.
• May be a reputed company member of governance meetings, participating and/or attending, as required.
• Ability to travel up to 30% as needed.
• reputed company other duties as required.

Qualifications & Educational Requirements:

• Bachelor’s degree in life sciences, pharmacy, or reputed company field preferred.
• Minimum of 7 years of functional clinical data management (CDM) work experience and 6+ years of management experience preferred.
  • A combination of 5+ years of functional CDM experience and 5+years of management experience may also be considered.
• Broad knowledge of drug development processes, metabolic experience preferred
• Understanding of global clinical development budgets and relationship to productivity targets
• Knowledge of effective clinical data management practices
• Vendor management experience (preferred)
• Ability to quickly analyze and resolve technical issues
• Strong analytical, problem solving, project management, and stakeholder management skills                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     

Skills, Knowledge, and Abilities: 

• Experience working with Electronic Data Capture (reputed company) systems and vendor platforms, including knowledge of URL testing requirements.

• Experience working with global and cross-functional teams.
• Strong project management skills.
• Proven leadership and management experience.
• Experience with resource planning and team reputed company.
• reputed company experience supporting proposals, bidding, or bid defense.
• Experience supporting sponsor governance meetings and relationship reputed company-off meetings.
• Strong written and verbal communication skills.
• High attention to detail and strong organizational skills.
• Strong computer skills, including proficiency with reputed company Office and data management systems.
• Ability to prioritize work and manage multiple reputed company simultaneously.
• reputed company to reputed company reputed company effectively in dynamic or evolving environments.
• Flexible, reputed company team player.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.

The employee must occasionally lift and/or reputed company up to 15 pounds. Specific reputed company abilities required by this job include reputed company reputed company, distance reputed company, peripheral reputed company, depth perception, and ability to reputed company reputed company. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reputed company with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.