Manager, Clinical Data Management
About The Position
The Manager, Clinical Data Management works under minimal supervision and may lead portions of a program, project and/or process and provide training and guidance to staff. In this role, the Manager, Clinical Data Management provides direct subject matter expertise to establish operational plans and implement products, processes and standards that have some impact on business results. This position applies in depth knowledge and experience to address complex problems that require an understanding of one or multiple related disciplines. This position reports to Data Acquisition Functional Leadership and represents Data Management in cross functional discussions, with the ability to influence key stakeholders and contribute to strategic discussions and decisions. This position may also participate in continuous improvement initiatives and industry work groups. This position develops strong and productive working relationships with key stakeholders within IDAR and Global Development, in addition to broader partners, external suppliers and/or industry groups.
Requirements
- Bachelor's degree (e.g., BS, BA) is required, preferably in Clinical Data Management, Health, or Computer Sciences.
- A minimum of 6 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required.
- In-depth knowledge of data management practices (including tools and processes) is required.
- In-depth knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., HL7 FHIR) is required.
- Advanced project and risk management skills with an established track record delivering successful outcomes is required.
- Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors is required.
- Excellent communication, leadership, influencing and decision-making skills is required.
- Excellent written and verbal communications skills is required.
Nice To Haves
- Advanced degrees preferred (e.g., Master, PhD).
- Innovative thinking to allow for optimal design and execution of clinical development strategies is preferred.
- Development and implementation of a business change/innovative way of working is preferred.
- Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms is preferred.
Responsibilities
- Planning, executi, and completion of all data acquisition activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
- Ensuring timely and effective maintenance of functional planning systems.
- Independently and effectively managing issue escalations, adopting appropriate escalation pathways.
- Anticipation, early detection, prevention and management of risks and issues impacting deliverables and activities.
- Leading or contributing to the development and maintenance of departmental policies, procedures, training, and standards.
- Contributing to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates.
- Contributing to the enhancement of functional, technical and/or scientific capabilities within data management.
- Influencing the external industry and/or regulatory environment through active engagement in industry forums and working groups.
- Supporting data acquisition related aspects of regulatory agency inspections and internal audits. Ensure real time inspection readiness for all data acquisition deliverables.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension)
- Savings plan (401(k))
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What This Job Offers
Job Type
Full-time
Career Level
Manager
