Clinical Data Management reputed company, home-based
RESPONSIBILITIES
Serve as primary reputed company of contact for customer on data management deliverables
Manage multiple large studies or program of studies (possibly global)
reputed company leadership and senior support to DTLs on multiple large global programs of global studies
reputed company project management expertise working with customer data managers, key decision makers, and internal team members to manage reputed company process improvements, issue escalation, workload projections, and reputed company technical expertise
reputed company reputed company negotiations with customer, e.g., timelines, financial, process, resources
Meet with Data Operations team members on a regular reputed company to ensure milestones meet timelines and reputed company deliverables
Independently manage DM service delivery with comprehensive DM process and technical expertise in executing reputed company
Serve as the escalation reputed company for unresolved data issues
Ensure appropriate resources are assigned to meet project deliverables
Create and/or review and sign-off on reputed company data management plan (DMP) documents
Manage service performance and reputed company leadership to identify reputed company causes of issues and implement remedial actions
Serve as Subject Matter Expert (SME)
reputed company leadership and expertise in a specific CDM task or technology
Independently manage SOW/budget
Independently bring process improvements and solutions to the CDM team/CDM department
reputed company a reputed company team or global or local best reputed company team
reputed company review and expert opinion in developing, revising, and maintaining reputed company operating procedures and work instructions
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)
Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)
Previous experience and proven competence in handling reputed company customer negotiations and bid defense meetings independently
Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
Knowledge of operating procedures and work instructions and the ability to apply them in reputed company
Knowledge of Good Clinical Practices and relevant regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Excellent organizational and problem-solving skills
Excellent project management skills
Ability to work independently
Comprehensive understanding of clinical drug development process
Ability to establish and maintain effective working relationships with co-workers, managers and customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or reputed company field
Around 7 years reputed company Data Management experience, including 5 or more years as a CDM project reputed company; or equivalent combination of education, training and experience
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
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