Director, Clinical Data Management - Hybrid
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to include sections only if posting has real specific content.
We need to preserve all substantive info, remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions.
We need to remove things like "EligibleforERP #GDMS Required Skills:" etc. Also remove "Current Employees apply HERE Current Contingent Workers apply HERE". Remove EEO statements, accommodation, etc. Remove "As a Federal Contractor..." etc. Remove "Search Firm Representatives Please Read Carefully..." etc. Remove "Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 09/26/2026 ...". Also remove "Requisition ID:R417692". Also remove "The salary range for this role is $173,200.00 - $272,600.00 ..."? Actually salary is Pay section, we need to include Pay if present. The posting includes salary range and bonus etc. So we should include Pay section with that info. Also benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits." So Benefits section.
Schedule? Not mentioned. There's "Travel Requirements: 10%" but not schedule. No explicit schedule. So we should not create Schedule section.
Qualifications & Experience: we have qualifications. Also "Required Skills:" list; "Preferred Skills:" list. Also there is a section "Technical Skills", "Non-technical Skills", "Enterprise Leadership Skills." Those could go under Skills? The instruction: Use headings for Skills (generic). We could combine all skill-related content under Skills heading. But we also have Qualifications heading for qualifications & experience. Also Responsibilities heading.
We also have "About the role" maybe from first paragraph: "The Director, Study Integration Manager leads a team and has portfolio-level oversight of study-integration delivery across programs and regions. This Director serves as senior technical authority—approving high-impact designs, governing standards at scale, balancing demand vs. capacity, and driving automation and operational excellence—while remaining close to the work through targeted reviews and coaching. Represents the function in internal/external forums and ensures consistent, audit-ready outcomes." That's about the role.
Thus sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay.
We need to ensure we don't include filler like "commensurate with experience". Not present.
We need to use - for any list of duties/requirements/benefits. So for Responsibilities we have bullet points? The responsibilities are given as paragraphs with sentences separated by semicolons. We could split into list items each sentence? The instruction: Use
- for any list of duties/requirements/benefits. The responsibilities are a list; we can convert each sentence (or each major bullet) into
- . Similarly for Qualifications maybe list? It's a paragraph with bullet-like items: "Bachelor’s Degree with a minimum of 10 year's experience working in relevant field for associated job description, including: 3 years people management experience." Then alternative: "Advanced Degree (Masters Or Doctorate) With a Minimum Of 8 Year's Experience Working In Relevant Field For Associated Job Description, Including: 3 years people management experience." Could be two options. We'll keep as
- .
Skills: we have Technical Skills, Non-technical Skills, Enterprise Leadership Skills. Could combine into one Skills section with subheadings? But we only allowed
for section headings; we could have nested ? Not specified. Probably better to keep as one Skills section with bullet list combining all skill statements. However we need to preserve all substantive info; we can list each skill as
- . Might be long but okay.
Benefits: list benefits.
Pay: include salary range and bonus info.
We must not include application instructions, etc.
Let's extract content.
First, About the role paragraph: "The Director, Study Integration Manager leads a team and has portfolio-level oversight of study-integration delivery across programs and regions. This Director serves as senior technical authority—approving high-impact designs, governing standards at scale, balancing demand vs. capacity, and driving automation and operational excellence—while remaining close to the work through targeted reviews and coaching. Represents the function in internal/external forums and ensures consistent, audit-ready outcomes."
We'll put that in
.
Responsibilities: The block after "Responsibilities:" includes several bullet-like sentences separated by semicolons and line breaks. Let's extract each distinct responsibility:
- Study technical planning & delivery
- Own the integrated plan from design through closeout across in-scope studies; synchronize releases and dependencies.
- Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release.
- Oversee decommissioning and archival with complete, audit-ready documentation.
- Directly lead critical or high-risk studies or cross-program integrations to unblock delivery and model best practices.
- Cross-functional coordination, risks & governance
- Set the program/TA technical strategy aligned to GDMS/DI&A goals; translate business objectives into executable technical roadmaps and outcomes.
- Participate as needed on the DI&A governance team; present decision-ready recommendations and trade-offs.
- Define and manage SOWs/SLAs/SLOs; track service provider delivery health and hold partners accountable for quality and timelines.
- Champion risk-based computer system validation (CSV) and inspection readiness in partnership with cross-functional teams.
- Coordinate internal audits (point of contact), including evidence, responses, and action plans.
- Communicate status, risks, and decisions to sponsors and governance forums with clear escalation paths.
- Build business cases and prioritize initiatives; define OKRs/KPIs and dashboards (quality, cycle time, cost, stability) and track value realized.
- Standards, quality & continuous improvement
- Act as design authority for data collection/flows, integrations, and validation patterns; arbitrate configure vs. customize decisions.
- Drive design consistency based on global and TA standards in all key deliverables part of clinical data management system.
- Provide technical consultancy on data architecture, metadata, and cross-system interoperability
- Mentor and coach junior team members; review plans/specs, uplift practices (agile, testing, automation), and create learning opportunities.
- Foster experiment/test-and-learn culture; sponsor communities of practice and reusable assets/templates.
- Lead strategic improvement initiatives (automation, CI/CD in validated contexts, test efficiency, MDR/metadata enablement), including introduction of new processes / technologies
- People Management
- Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
- Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
- Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
- Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
- Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
- Manage an operating budget and optimize spend against priorities.
- Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders.
We could flatten all these into a single list of duties. But maybe better to keep subheadings? Not allowed. We'll just make a flat list.
Qualifications & Experience: The paragraph:
"Qualifications & Experience: Bachelor’s Degree with a minimum of 10 year's experience working in relevant field for associated job description, including: 3 years people management experience.Demonstrated deep subject matter expertise in relevant discipline OR Advanced Degree (Masters Or Doctorate) With a Minimum Of 8 Year's Experience Working In Relevant Field For Associated Job Description, Including: 3 years people management experience.Demonstrated deep subject matter expertise in relevant discipline clinicaltrialjobs EligibleforERP #GDMS"
There's some weird text "clinicaltrialjobs EligibleforERP #GDMS" maybe from tags. We should remove that as boilerplate? It's not substantive. Probably remove.
Thus qualifications: two options:
Option 1: Bachelor’s Degree with minimum 10 years experience in relevant field, including 3 years people management experience, and demonstrated deep subject matter expertise in relevant discipline.
Option 2: Advanced Degree (Masters or Doctorate) with minimum 8 years experience in relevant field, including 3 years people management experience, and demonstrated deep subject matter expertise in relevant discipline.
We'll capture that.
Skills: We have sections:
Technical Skills:
- Demonstrated ability to review and approve complex designs and integration patterns; optimize mappings, error handling, and data lineage.
- Deep knowledge of data capture, aggregation, consumption, and flow.
- Ability to independently lead study-level design/build/test/release; author/peer-review specs (eCRF, edit checks, mappings).
- Strong hands-on with clinical data management (CDM) systems; working proficiency across multi-system data flows and API-based or file integrations.
- Understanding of clinical, data, and sponsor standards.
Non-technical Skills:
- Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions
- Drives adoption of standardized methods/ways of working; mobilizes cross-functional champions and measures uptake
- Aligns senior stakeholders on objectives, interfaces, and responsibilities; enforces clean handoffs and resolves conflicts
- Ability to coordinate decisions across regions/time zones; uses asynchronous mechanisms to maintain momentum
- Engages service provider, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure
- Ability to define and execute organizational strategy for operations across regions
- Demonstrated success managing large, and geographically distributed teams
- Strong understanding of operational, financial, and compliance dimensions of global data delivery
- Capable of leading transformation initiatives and fostering innovation across complex organizations
- Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction
- Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback
Enterprise Leadership Skills:
- Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.
- Networking & Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.
- Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change.
We'll combine all these into Skills section as list items.
Benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and
- for any list of duties/requirements/benefits. The responsibilities are a list; we can convert each sentence (or each major bullet) into
- . Similarly for Qualifications maybe list? It's a paragraph with bullet-like items: "Bachelor’s Degree with a minimum of 10 year's experience working in relevant field for associated job description, including: 3 years people management experience." Then alternative: "Advanced Degree (Masters Or Doctorate) With a Minimum Of 8 Year's Experience Working In Relevant Field For Associated Job Description, Including: 3 years people management experience." Could be two options. We'll keep as
- .
Skills: we have Technical Skills, Non-technical Skills, Enterprise Leadership Skills. Could combine into one Skills section with subheadings? But we only allowed
for section headings; we could have nested
? Not specified. Probably better to keep as one Skills section with bullet list combining all skill statements. However we need to preserve all substantive info; we can list each skill as
- . Might be long but okay.
Benefits: list benefits.
Pay: include salary range and bonus info.
We must not include application instructions, etc.
Let's extract content.
First, About the role paragraph: "The Director, Study Integration Manager leads a team and has portfolio-level oversight of study-integration delivery across programs and regions. This Director serves as senior technical authority—approving high-impact designs, governing standards at scale, balancing demand vs. capacity, and driving automation and operational excellence—while remaining close to the work through targeted reviews and coaching. Represents the function in internal/external forums and ensures consistent, audit-ready outcomes."
We'll put that in
. Responsibilities: The block after "Responsibilities:" includes several bullet-like sentences separated by semicolons and line breaks. Let's extract each distinct responsibility: - Study technical planning & delivery - Own the integrated plan from design through closeout across in-scope studies; synchronize releases and dependencies. - Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release. - Oversee decommissioning and archival with complete, audit-ready documentation. - Directly lead critical or high-risk studies or cross-program integrations to unblock delivery and model best practices. - Cross-functional coordination, risks & governance - Set the program/TA technical strategy aligned to GDMS/DI&A goals; translate business objectives into executable technical roadmaps and outcomes. - Participate as needed on the DI&A governance team; present decision-ready recommendations and trade-offs. - Define and manage SOWs/SLAs/SLOs; track service provider delivery health and hold partners accountable for quality and timelines. - Champion risk-based computer system validation (CSV) and inspection readiness in partnership with cross-functional teams. - Coordinate internal audits (point of contact), including evidence, responses, and action plans. - Communicate status, risks, and decisions to sponsors and governance forums with clear escalation paths. - Build business cases and prioritize initiatives; define OKRs/KPIs and dashboards (quality, cycle time, cost, stability) and track value realized. - Standards, quality & continuous improvement - Act as design authority for data collection/flows, integrations, and validation patterns; arbitrate configure vs. customize decisions. - Drive design consistency based on global and TA standards in all key deliverables part of clinical data management system. - Provide technical consultancy on data architecture, metadata, and cross-system interoperability - Mentor and coach junior team members; review plans/specs, uplift practices (agile, testing, automation), and create learning opportunities. - Foster experiment/test-and-learn culture; sponsor communities of practice and reusable assets/templates. - Lead strategic improvement initiatives (automation, CI/CD in validated contexts, test efficiency, MDR/metadata enablement), including introduction of new processes / technologies - People Management - Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability. - Conduct regular check-ins and annual reviews; coach for performance; provide recognition. - Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring. - Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR. - Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs. - Manage an operating budget and optimize spend against priorities. - Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders. We could flatten all these into a single list of duties. But maybe better to keep subheadings? Not allowed. We'll just make a flat list. Qualifications & Experience: The paragraph: "Qualifications & Experience: Bachelor’s Degree with a minimum of 10 year's experience working in relevant field for associated job description, including: 3 years people management experience.Demonstrated deep subject matter expertise in relevant discipline OR Advanced Degree (Masters Or Doctorate) With a Minimum Of 8 Year's Experience Working In Relevant Field For Associated Job Description, Including: 3 years people management experience.Demonstrated deep subject matter expertise in relevant discipline clinicaltrialjobs EligibleforERP #GDMS" There's some weird text "clinicaltrialjobs EligibleforERP #GDMS" maybe from tags. We should remove that as boilerplate? It's not substantive. Probably remove. Thus qualifications: two options: Option 1: Bachelor’s Degree with minimum 10 years experience in relevant field, including 3 years people management experience, and demonstrated deep subject matter expertise in relevant discipline. Option 2: Advanced Degree (Masters or Doctorate) with minimum 8 years experience in relevant field, including 3 years people management experience, and demonstrated deep subject matter expertise in relevant discipline. We'll capture that. Skills: We have sections: Technical Skills: - Demonstrated ability to review and approve complex designs and integration patterns; optimize mappings, error handling, and data lineage. - Deep knowledge of data capture, aggregation, consumption, and flow. - Ability to independently lead study-level design/build/test/release; author/peer-review specs (eCRF, edit checks, mappings). - Strong hands-on with clinical data management (CDM) systems; working proficiency across multi-system data flows and API-based or file integrations. - Understanding of clinical, data, and sponsor standards. Non-technical Skills: - Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions - Drives adoption of standardized methods/ways of working; mobilizes cross-functional champions and measures uptake - Aligns senior stakeholders on objectives, interfaces, and responsibilities; enforces clean handoffs and resolves conflicts - Ability to coordinate decisions across regions/time zones; uses asynchronous mechanisms to maintain momentum - Engages service provider, leadership, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure - Ability to define and execute organizational strategy for operations across regions - Demonstrated success managing large, and geographically distributed teams - Strong understanding of operational, financial, and compliance dimensions of global data delivery - Capable of leading transformation initiatives and fostering innovation across complex organizations - Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction - Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback Enterprise Leadership Skills: - Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values. - Networking & Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals. - Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change. We'll combine all these into Skills section as list items. Benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and
- .
Skills: we have Technical Skills, Non-technical Skills, Enterprise Leadership Skills. Could combine into one Skills section with subheadings? But we only allowed