Global Clinical Data Standards, Senior Therapeutic Area Lead - Hybrid

Merck • North Wales, PA

1d • Hybrid

About The Position

The Senior GCDS TA Lead is a subject matter expert in data standards for support of clinical data collection and/or transformation management that is compliant with health authority regulations. Primary activities may include, but are not limited to: Providing operational expertise and guidance through training development, training delivery and mentoring to members of the Global Clinical Data Standards team. Maintaining the integrity of standards libraries, ensuring processes as defined in SOPs and work instructions are in alignment with our company quality documentation standards. Maintaining knowledge of new and evolving industry and health authority guidance; assess impact to our Company's current implementation of end-to-end data standards. Influencing industry strategic direction and clinical data standards development through active participation in industry organizations and forums. Maintain a communication network among industry peers for the purpose of identifying innovative processes and technology and best practices. 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. In conjunction with senior leadership, participate in corporate initiatives by providing guidance and direction in evaluating, re-engineering, designing, implementing, benchmarking, and training for new or enhanced processes, procedures, and technology. Encourage practical applications of new ideas. Provide expertise on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines. Work with leadership to define and implement KPIs and quality metrics reporting to assure high quality standard components. Lead and represent GCDS on TAST as required to ensure consistency across the various projects and protocols within the therapeutic areas. Ensure all therapeutic area work complies with the current standards. Support the teams in their development of new and modified standards and submission to the required governing bodies. Lead the review of departmental SOPs, reference documents, execution resources and implementation strategies. Promote teamwork across GCDS by actively communicating and proactively sharing information.

Requirements

• B.A. or B.S. degree, preferably in life sciences, computer science or related discipline.
• 10 years’ work experience which includes 6 years of data management experience and a minimum 4 years in clinical data standards development.
• In-depth (advanced) knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).
• Expertise in various forms of data collection (e.g., eCRF, IRT, Central Lab Data)
• Study Data Tabulation Model (SDTM) expertise
• Understanding of clinical data requirements for Analysis & Reporting
• Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
• Comprehensive knowledge of the clinical trial process including data management (e.g., data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.
• Advanced knowledge in two or more therapeutic areas
• Ability to work with clinical teams to assure consistency across all studies in a clinical development program and/or therapeutic area.
• Exceptional education/training/facilitation skills
• Ability to mentor cross functional colleagues in data standards and metadata management practices.
• Experience in defining and implementing continuous improvement projects
• Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.
• Ability to influence and drive decision making
• Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems.
• Ability to effectively organize and manage multiple assignments with challenging timelines.
• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas
• Exceptional demonstrated organizational, problem-solving and negotiating skills

Nice To Haves

• Knowledge of clinical data metadata & information management platforms and systems
• 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

• Providing operational expertise and guidance through training development, training delivery and mentoring to members of the Global Clinical Data Standards team.
• Maintaining the integrity of standards libraries, ensuring processes as defined in SOPs and work instructions are in alignment with our company quality documentation standards.
• Maintaining knowledge of new and evolving industry and health authority guidance; assess impact to our Company's current implementation of end-to-end data standards.
• Influencing industry strategic direction and clinical data standards development through active participation in industry organizations and forums. Maintain a communication network among industry peers for the purpose of identifying innovative processes and technology and best practices.
• 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.
• In conjunction with senior leadership, participate in corporate initiatives by providing guidance and direction in evaluating, re-engineering, designing, implementing, benchmarking, and training for new or enhanced processes, procedures, and technology. Encourage practical applications of new ideas.
• Provide expertise on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.
• Work with leadership to define and implement KPIs and quality metrics reporting to assure high quality standard components.
• Lead and represent GCDS on TAST as required to ensure consistency across the various projects and protocols within the therapeutic areas.
• Ensure all therapeutic area work complies with the current standards. Support the teams in their development of new and modified standards and submission to the required governing bodies.
• Lead the review of departmental SOPs, reference documents, execution resources and implementation strategies.
• Promote teamwork across GCDS by actively communicating and proactively sharing information.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees