CommunicationRegulatory ComplianceLeadershipKey Performance Indicators

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., We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote".

The salary range for this role is $173,200.00 - $272,600.00, Hybrid CommunicationRegulatory ComplianceLeadershipKey Performance Indicators (KPIs)Training And DevelopmentTeamworkManagementMentorshipAccountabilityLife SciencesClinical TrialsProcess ImprovementInnovationContinuous Improvement ProcessInfluencing SkillsResearchComputer ScienceEthical Standards And ConductProblem SolvingNegotiationStakeholder ManagementTelecommutingDecision MakingInterpersonal CommunicationsWorkday (Software)Data GovernancePre-Clinical DevelopmentData ModelingData ManagementClinical Data ManagementGood Clinical Practices (GCP)Data CollectionInformation SystemsContingent WorkforceBenchmarkingTelephone SkillsDrug DiscoveryMetadata ManagementInformation ManagementCompassionRequirements ElicitationDisabilitiesData ValidationMetadataData TransformationTelecommunications NetworksHealth Level Seven (HL7)Arc Digitized Raster GraphicInteractive Response TechnologyReengineeringCase Report FormsTraining FacilitationTraining Delivery

• B.A. or B.S. degree, preferably in life sciences, computer science or related discipline.

Experience:

• 10 years' work experience which includes 6 years of data management experience and a minimum 4 years in clinical data standards development.

Knowledge and Skills:

• 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

Knowledge and Skills Desirable but not Essential

• 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., Accountability, Clinical Data, Clinical Data Management, Clinical Development, Clinical Study Protocols, Clinical Trials, Communication Network, Data Validation, Decision Making, Drug Discovery Process, Ethical Standards, Good Clinical Practice (GCP), Information Systems Management, Mentoring Staff, Metadata Management, Negotiation, Regulatory Compliance, Stakeholder Management, Standards Development

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.