Associate Director, Program Manager, Clinical Data Standards

MSD•North Wales, PA

3d•Hybrid

About The Position

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. Projects will have set timeframes. 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), demonstrate deep SME (Subject Matter Expert) skill in relevant discipline.
OR Advanced Degree (master's or doctorate) and minimum of 4 year’s experience in Program Management of which 3 years needs to be in clinical research, data management, or metadata management (or related discipline), demonstrate deep SME skill in relevant 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 tool.
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.
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
Proven ability to work collaboratively on interdisciplinary teams.
Strong interpersonal skills that demonstrate initiative and motivation.
Proven ability to solve complex problems.
Strong skills in project management
Ability to effectively organize and manage multiple assignments with challenging timelines.
Ability to mentor cross functional colleagues in data standards and metadata management practices.
Accountability
Adaptability
Clinical Database Programming
Clinical Data Management
Clinical Data Standards
Clinical Trials
Data Analysis
Data Governance
Data Quality Assurance
Data Reporting
Data Validation
Detail-Oriented
Good Clinical Data Management Practice (GCDMP)
Good Clinical Practice (GCP)
International Regulatory Compliance
Interpersonal Relationships
Leadership
Mentoring Staff
Metadata Management
Process Improvement Projects
Project Management

Nice To Haves

Direct experience implementing industry standards.
In-depth knowledge in industry data standards, regulatory data submission requirements, and demonstrated experience in the development and implementation of standard methodology.
Knowledge of clinical data management systems (e.g., Inform, Rave).
Knowledge of SAS and statistical methodologies.
Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.
Ability to use programming and other applications to generate insights from data.

Responsibilities

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.