Senior Manager, Clinical Data Management

POSTION SUMMARY

 The Senior Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and data reporting aspects. In addition, the Senior Manager will lead the development of systems and procedures to assure consistency across the Clinical Data Management department.   Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals in accordance with Standard Operating Procedures (SOPs) and regulatory directives. Participate in staff recruitment, onboarding, training and mentoring. 

PRIMARY RESPONSIBILITIES

• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies, build effective relationships with CRO/vendor counterparts
• Able to review and provide feedback to the multi-disciplinary team on other study documents e.g. clinical study protocols, protocol deviation plans, medical monitoring plan, statistical analysis plan, mock Tables, Figures and Listings (TFL) shells and Clinical Study Reports (CSRs)
• Reviews and approves DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, Validation Plan, User Acceptance Testing (UAT) documentation, Data Review Plan, etc.
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
• Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc., and related best practices
• Attends and represents CDM effectively on all assigned studies and programs at relevant meetings.
• Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
• Manage the clinical study budget, ensuring the project remains within scope through reviewing and approving invoices, identifying out-of-scope activities and its appropriate handling
• Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
• Monitor in-house resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles
• Contribute to developing and implementing departmental policies, standards and process improvement initiatives as needed
• Support implementation of data standards
• Align with and support management and corporate goals or objectives
• Contribute to activities supporting audits & inspection readiness and regulatory inspections
• Assist in selecting vendors/CROs e.g. reviewing RFIs/RFPs and participating in bid defenses
• Identify, manage, mentor and develop Clinical Data Management team members
• Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations relating to data management activities

QUALIFICATIONS

Education/Experience

• Bachelor’s Degree preferably in a scientific or health-related discipline; Master’s degree is a plus
• 8+ years of clinical data management experience in a pharmaceutical/biotech setting

Knowledge, Skills and Abilities

• Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives
• Experience in managing outsourced clinical data management activities and/or other vendors
• Thorough understanding of the drug development process, clinical trial methodology, regulatory requirements, ICH, GCP and GCDMP
• Current and extensive knowledge of industry CDM best practices and processes
• Strong experience with various clinical database management systems including EDC, eCOA, and ePRO
• Strong and effective oral and written communication, project management, and interpersonal skills
• Proven success working in a virtual, global and multi-cultural environment
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Proven success in identifying creative solutions to complex study-related or technical issues
• Knowledge of SAS, EDC programming, systems integration experience
• Solid understanding of CDASH and CDISC standards
• Ability to mentor junior staff

The salary range for this position is $185,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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