Mirumpharma
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals, and we’re looking to augment our team with individuals who embody our values: care, be real, get it done, and have fun, seriously.
Position Summary The Senior Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and reporting aspects. The role involves developing systems and procedures to ensure consistency across the Clinical Data Management department, supporting activities from study start-up through study closure in line with SOPs and regulatory directives. The position also includes staff recruitment, onboarding, training, and mentoring.
Primary Responsibilities
Manage and monitor data management activities with CROs or vendors, building effective relationships.
Review and provide feedback on study documents such as protocols, deviation plans, monitoring plans, analysis plans, TFL shells, and CSR.
Approve DM documentation for quality and accuracy, including CRFs, Data Validation Specifications, Data Management Plans, Data Transfer Agreements, and others.
Track and report progress towards data deliverables using effective metrics.
Develop procedures for data quality review and acceptance prior to analysis or database lock.
Maintain knowledge of coding dictionaries like MedDRA and WHOdrug, and best practices.
Represent CDM at relevant meetings and ensure milestones are met.
Manage the clinical study budget, including invoice review and scope management.
Collaborate with biostatistics, programming, and other teams to meet project timelines.
Monitor resources and address potential deficiencies.
Contribute to departmental policies, standards, and process improvements.
Support data standards implementation and audit readiness.
Assist in vendor/CRO selection processes.
Mentor and develop team members.
Maintain knowledge of medical terminology, ICH guidelines, and data management regulations.
Qualifications Education/Experience
Bachelor’s Degree in a scientific or health-related discipline; Master’s preferred.
8+ years of clinical data management experience in pharma/biotech.
Knowledge, Skills, and Abilities
Ability to prioritize multiple tasks with conflicting deadlines.
Experience managing outsourced data activities and vendors.
Understanding of drug development, clinical trial methodology, and regulatory requirements.
Knowledge of industry best practices and systems like EDC, eCOA, ePRO.
Strong communication, project management, and interpersonal skills.
Experience working in a virtual, global, multi-cultural environment.
Attention to detail and ability to work independently and in teams.
Problem-solving skills for technical and study-related issues.
Knowledge of SAS, EDC programming, and systems integration.
Understanding of CDASH and CDISC standards.
Ability to mentor junior staff.
#LI-ONSITE
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and compliance with all applicable laws. We provide reasonable accommodations for qualified individuals with disabilities and disabled veterans.
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Position Summary The Senior Manager, Clinical Data Management will collaborate primarily with internal team members and external vendors to manage all data collection and reporting aspects. The role involves developing systems and procedures to ensure consistency across the Clinical Data Management department, supporting activities from study start-up through study closure in line with SOPs and regulatory directives. The position also includes staff recruitment, onboarding, training, and mentoring.
Primary Responsibilities
Manage and monitor data management activities with CROs or vendors, building effective relationships.
Review and provide feedback on study documents such as protocols, deviation plans, monitoring plans, analysis plans, TFL shells, and CSR.
Approve DM documentation for quality and accuracy, including CRFs, Data Validation Specifications, Data Management Plans, Data Transfer Agreements, and others.
Track and report progress towards data deliverables using effective metrics.
Develop procedures for data quality review and acceptance prior to analysis or database lock.
Maintain knowledge of coding dictionaries like MedDRA and WHOdrug, and best practices.
Represent CDM at relevant meetings and ensure milestones are met.
Manage the clinical study budget, including invoice review and scope management.
Collaborate with biostatistics, programming, and other teams to meet project timelines.
Monitor resources and address potential deficiencies.
Contribute to departmental policies, standards, and process improvements.
Support data standards implementation and audit readiness.
Assist in vendor/CRO selection processes.
Mentor and develop team members.
Maintain knowledge of medical terminology, ICH guidelines, and data management regulations.
Qualifications Education/Experience
Bachelor’s Degree in a scientific or health-related discipline; Master’s preferred.
8+ years of clinical data management experience in pharma/biotech.
Knowledge, Skills, and Abilities
Ability to prioritize multiple tasks with conflicting deadlines.
Experience managing outsourced data activities and vendors.
Understanding of drug development, clinical trial methodology, and regulatory requirements.
Knowledge of industry best practices and systems like EDC, eCOA, ePRO.
Strong communication, project management, and interpersonal skills.
Experience working in a virtual, global, multi-cultural environment.
Attention to detail and ability to work independently and in teams.
Problem-solving skills for technical and study-related issues.
Knowledge of SAS, EDC programming, and systems integration.
Understanding of CDASH and CDISC standards.
Ability to mentor junior staff.
#LI-ONSITE
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and compliance with all applicable laws. We provide reasonable accommodations for qualified individuals with disabilities and disabled veterans.
#J-18808-Ljbffr