Senior Manager, Clinical Data Management

Mirum Pharmaceuticals•Foster City, CA

5d•$185,000 - $205,000•Hybrid

About The Position

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.

Requirements

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
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

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