Principal eClinical Data Strategist

Almac Group is currently seeking a Principal eClinical Data Strategist for our Lansdale location. The Principal eClinical Data Strategist is a senior individual-contributor responsible for leading the definition, governance, and continuous enhancement of Almac's Clinical Data Management (CDM) standards, policies, and data strategy across its eClinical solutions. This role focuses on establishing cohesive, inspection-ready standards and processes across the organization and guiding teams on best practices for clinical data handling to ensure compliance with global regulatory expectations. *This is a hybrid role Responsibilities include but are not limited to: Clinical Data Management (CDM) Standards / Best Practices / SOPs / Templates: 1. Define, maintain, and proactively develop CDM standards, best practices, SOPs, and templates (e.g., plans for data management, transfer, review). 2. Establish clear definitions for data types (e.g., source, electronic source, created, owned), ownership/stewardship, data handling rules (security, acceptability), privacy/PII controls, and standards for data editing, cleaning, mapping, storage, and retrieval across all Almac eClinical services. 3. Ensure cohesive CDM processes across cross-functional areas. 4. Work cross-functionally to implement. CDM Regulatory & Compliance Leadership: 1. Serve as Almac's internal expert on regulatory expectations impacting electronic clinical and eCOA data (ICH E6(R3)/E8(R1), FDA PRO/eCOA guidance, 21 CFR Part 11, GDPR). 2. Translate regulatory changes and industry trends into updated and new SOPs, standards, and required documentation; provide expert support for audits, inspections, and system validation readiness. 3. Work cross-functionally to implement, educate and ensure compliance. eCOA Standards / Best Practices Development: 1. Lead the development, maintenance, and expansion of Almac's eCOA standards / best practices and policies, including validated instrument implementation, scoring conventions, versioning/translation control, metadata management, compliance and missing data conventions, and audit trail requirements to ensure scientifically robust, endpoint-quality eCOA data. 2. Work cross-functionally to implement. Policies & Procedures for Controlled Access of High-Risk Data: 1. Create policies and procedures governing controlled access for high-risk data (e.g., PII, randomization data) during live studies (what/when/how), including DMC and safety review needs while preserving blinding integrity 2. Work cross-functionally to implement. Best Practices / Standards for Clinical Integrations, Data Transfers, and Data Outputs (Reports, Exports) Work cross-functionally with product management and data services to ensure consistency, traceability, operational utility, and regulatory fitness: 1. Integration and data transfer patterns across eClinical systems (IRT, eCOA, EDC, CTMS, CDMS, sponsor systems) with clear expectations for reliability, reconciliation, monitoring, and supportability. 2. Reusable data transfer suite (scheduled, event-driven, ad hoc extracts, APIs) including formats, metadata, frequencies, and error-handling rules. 3. Stakeholder-specific outputs (e.g., Clinical Supplies data, Biostatistics randomization extracts, operational oversight reports). 4. Endpoint-quality eCOA data Internal health-check exports / reports to support monitoring, quality oversight, and internal readiness. 5. CDISC SDTM/ADaM-aligned deliverables, including traceability, documentation standards, and metadata expectations Lead CDM Process Improvement Initiatives Drive key process improvement initiatives while facilitating cross-functional alignment: 1. Lead CDM initiatives and strategic workstreams that modernize data standards, workflows, and practices across eClinical solutions. 2. Provide expert guidance to internal teams on Almac's CDM standards / SOPs, and support issue resolutions, escalations, challenges. 3. Champion CDM technology and tooling improvements that enhance automation, data quality, consistency, and efficiency. 4. Identify and evaluate CDM, data, and process issues; develop strategic solutions; and lead the design and rollout of optimized practices across all affected functions. 5. Establish compliance monitoring mechanisms to identify risks, deviations, or improvement opportunities-proposing and driving mitigation strategies. 6. Build strong relationships across functions as an eClinical SME to ensure cohesive execution of standards, aligned decision-making, and unified quality expectations. Business Continuity, Vendor Ecosystem Management & Client Partnership Strengthen Almac's business continuity, client relationships, and external partnerships by ensuring alignment between Almac standards, partner capabilities, client needs, and evolving industry direction: 1. Manage relationships with external eClinical vendors / partners to ensure alignment with Almac's data standards and integration approaches. 2. Monitor industry trends, regulatory developments, emerging technologies, and sponsor expectations to keep Almac's CDM service offerings current / competitive. 3. Engage with clients to consult on complex CDM / eClinical data challenges, manage escalated issues, support business development opportunities, and maintain strong client partnerships. 4. Identify external risks that may impact business continuity; recommend mitigation strategies to preserve consistency, compliance, and reliability. 5. Advise internal leadership on market insights, client needs, and partner capabilities to support long-term data strategy, product evolution, and service model planning. Qualifications: Required Experience / Education: 1. Bachelor's Degree in scientific or healthcare-related field 2. 7+ years of clinical data management or a similar role in pharmaceutical or clinical research industry (e.g., eClinical, pharmaceutical, biotech, or medical device industry/company). 3. Experience with various e-clinical technologies/software systems (including eCOA with validated instruments used for endpoints) 4. Demonstrated experience creating and governing SOPs, standards, templates, frameworks, and policies. 5. Experience communicating directly with clients. Required Knowledge: Deep understanding of clinical data management processes / best practices Understanding of drug development process, and clinical trial design Deep knowledge of global regulatory expectations related to eClinical software and data management