Associate Director, Program Manager, Clinical Data Standards

Role Overview

• The Program Manager oversees the projects and or activities within Global Clinical Data Standards purview and the associated clinical information governance network in collaboration with the Director of Operations, Global Clinical Data Standards.
• They monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables using a consistent project management methodology.
• Through teamwork and a data driven approach, they would work analytically and creatively to solve problems.
• Coordinates our Company’s standards governance network and facilitates our Company participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate).
• Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal requirements of our Company.
• Primary activities include, but are not limited to: Ensure individual projects are completed on time, within budget, and in alignment with company goals.
• Prepare and manage project materials. Including a project plan, RACI, meeting materials (e.g., notes, decision log, action items, etc.), timeline, kick-offs, retrospective reviews.
• Establish appropriate metrics to track and monitor progress and quality (as necessary).
• Bring together team members. Communication with and motivation of stakeholders. Addressing pain points, risks, and maintaining quality control.
• Prepare and maintain project status reports. Ability to organize and run meetings efficiently. Ability to show critical thinking and a "think-on-your-feet" mindset.
• Lead/participate in cross-functional data governance reviews and projects. Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives.
• Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company .
• Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and our Company's guidelines and SOPs.
• Define and oversee implementation of a standards communication plan.
• Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across our Company's multiple sites.
• Mentors, guides, and provides project leadership for junior staff as assigned.

Requirements

• Bachelors of Arts or Sciences and minimum of 8 years’ experience in Program Management of which 3 years needs to be in clinical research, data management, or metadata management (or related discipline)
• OR Advanced Degree (master's or doctorate) and minimum of 4 years experience in Program Management of which 3 years needs to be in clinical research, data management, or metadata management (or related discipline)
• Broad knowledge of and experience with clinical development & data management processes and regulatory requirements
• Extensive program and/or project management experience managing and governing clinical information standards activities.
• Awareness of industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (SDRG, ADRG, Define.xml)
• Must have awareness of project management methodologies (e.g., Scrum, Agile, Waterfall) and tools.
• Experience in defining, implementing, and managing process improvement projects and documentation.
• A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.
• Exceptional verbal and written communication skills in a global environment, with the ability to communicate with both the technical and business stakeholders.
• Exceptional people and thought leadership skills, with the ability to think strategically, influence others and work collaboratively with cross-functional stakeholders.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days