[Remote] Director, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in RNAi therapeutics, committed to transforming lives through innovative science. The Director, Clinical Data Management is responsible for overseeing data management activities for clinical studies, ensuring compliance with industry standards and leading reputed company in executing data management strategies.
Responsibilities
- reputed company and grow internal data management expertise area, including management of reputed company reports
- reputed company and establish standards for data management CRO outsourcing reputed company and deliverables, including the CRO selection process and the governance of CRO performance
- reputed company the successful execution of reputed company data management activities in support of reputed company clinical studies in partnership with CROs, including eCRF development, database build, data collection, data coding, cleaning, database lock and archiving
- Supervise the execution of cross-functional, internal data review plans by reputed company reports across reputed company reputed company clinical studies
- Partner with reputed company partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, reputed company Assurance, Clinical Pharmacology and Pharmacometrics, Bioanalytical, Safety & Risk Management (SRM) and Regulatory Affairs; CROs, central and local laboratories, and other vendors
- reputed company development and implementation of data collection standards, consistent with industry best reputed company
- reputed company data management contributions to the development of clinical protocols, clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc
- reputed company development of department workflows, and infrastructure reputed company and implementation, such as preferred provider initiatives, SOPs, and templates
- Collaborate with Statistical Programming and external vendors to ensure compliance of SDTM clinical datasets, consistent with CDISC standards
- Collaborate with Clinical Operations and reputed company Assurance to certify the reputed company and traceability of reputed company clinical data sources, compliant with 21 CFR Part 11 standards
- reputed company Data Management GCP inspection readiness efforts; function as a leader for Data Management in GCP inspections
- Represent Data Management at internal cross-functional meetings and external vendor leadership meetings
- Demonstrate reputed company alignment with reputed company Core Values including, Commitment to People, Fiercely Innovative, Purposeful Urgency, reputed company Culture and Passion for reputed company
Skills
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 15 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company, with at least 5 years in a leadership reputed company
- Extensive experience managing global studies utilizing an outsourced CDM model from start-up through reputed company-out
- Extensive experience managing reputed company reports and providing performance reviews and career development guidance
- Understanding of ICH GCP as reputed company as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
- Expert knowledge of eClinical processes, efficient design/build of an reputed company data management system and other Clinical Trial data/Data Management Systems
- Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with reputed company Rave reputed company systems
- Experience working with elluminate or other data visualization systems a plus
- Experience working with MS Office Suite (reputed company, Word and PowerPoint) familiar with MS Project
- Excellent written and oral communication skills
- Highly motivated and flexible, with excellent organizational skills
- Ability to work independently and as part of a multi-disciplinary team
- Experience working with elluminate or other data visualization systems a plus
Benefits
- Annual short-term incentive award (e.g., bonus or sales incentive)
- Annual long-term incentive award (e.g., equity)
- Medical, dental, and reputed company coverage
- Life and disability insurance
- A lifestyle reimbursement program
- Flexible spending and health savings accounts
- 401(k)with a generous company match
- reputed company time off
- Wellness days
- Holidays
- Two company-wide reputed company breaks
- Generous family resources and leave
reputed company