Associate Director Clinical Business Operations
Company: System One
Posted on: May 8, 2022
Job DescriptionJob Title: Associate Director Clinical Business
OperationsLocation: Remote Type: Full Time, Salaried with
Growing Biotech Company is hiring an Associate Director of Clinical
Business Operations to join their team! This individual will be
responsible for owning clinical systems supporting clinical
- Identify new process improvement opportunities. Leverage
clinical systems data to improve transparency, efficiency, and
compliance in Clinical Operations.
- Ensure our client's study management process is well supported
by clinical systems and aligned with business requirements.
- Ensure alignment and consistency of study timelines and
milestones between Clinical Operations, Global Project Management
- Ensure SOPs and guidance documents related to the use of
clinical systems, including its integration with other business
systems appropriately supports our client's study management
- Develop and maintain a 3-5-year Strategic Roadmap outlining the
timing and sequencing for delivering key business capabilities (new
systems) and enhancements to the existing systems to support
business needs over the long term.
- Create and implement change management strategies and plans
that maximize employee adoption and usage and minimize
- Partner with Global Project Management to ensure consistency
between Veeva and MS Project
- Work with stakeholders to support the business
- Lead the clinical systems information analytics to support our
client's study metrics analysis. Engage cross functional teams to
support the use of our client's Clinical Dashboards and
- Lead CTMS Data Standards to ensure streamlined data entry and
workflows supporting business requirements of stakeholders.
- Manage end user system support functions according to service
level agreements, including: facilitation of user access process,
triaging end user workflow/data entry issues
- Partner with IT for the technical management and support of the
- Oversee and integrate the CTMS Implementation Plan into the
operating model and budget, preparing for optimal
operationalization of capabilities as it is delivered by the
implementation team over a multi-year period. Minimum Required:
- Bachelor's Degree
- 10+ years of biotech, pharma and/or CRO experience, includes
relevant experience in clinical systems, including CTMS (Veeva
preferred) and/or clinical project management.
- Demonstrated strong governance management in a fast paced
matrixed setting, including the abilities to inform strategic
decisions, to facilitate and negotiate through complex strategic
decisions, to communicate with executive leadership, and lead
through influence within matrix teams.
- Solid foundation in data governance principles and experience
managing large data sets.
- Working knowledge of ICH-GCP guidelines and major Health
- Proven ability to establish productive working relationships
across large organizations, communicate well at all levels, and to
work collaboratively to build strong partnerships.
- Working knowledge of and experience with Medidata Rave EDC,
preferably Medidata Rave
- Experience collaborating and working with vendors, including
CROs, Labs, software and consulting services.
- Understanding of Quality management system (including computer
system validation practices)
- MS project or other GANTT charting and milestone development is
a plusJoule, a System One division is a leader in specialized
workforce solutions and integrated services. With more than 6,000
employees and roughly 50 offices throughout the U.S. we provide
scientific, clinical, engineering, energy, IT, legal and
administrative staffing services. For more than 40 years, we have
delivered workforce solutions and integrated services to clients
Keywords: System One, Potomac , Associate Director Clinical Business Operations, Executive , Potomac, Maryland
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