Principal, eClinical Data Management

Almac is currently seeking a Principal, eClinical Data Management for our Lansdale, PA office. The Principal, eClinical Data Management is responsible for the development of data management, integration and reporting standards in support of Almac Clinical Technologies’ products and services supporting clinical trials and ensuring conformance to regulatory / industry standards and best practices. The Principal, eClinical Data Management ensures that high quality data is obtained, processed, shared, managed and/or reported to sponsors or third parties and defines the approaches used to provide these services.

This is a hybrid role

Responsibilities include but are not limited to:

• Definitions for data types, including but not limited to source, electronic source, received, created (direct events performed), owned (data directly created and acceptable independent use).
• Ownership of each data type (e.g., source, metadata) within the trial under GCP by whom.
• Incoming data (e.g., information security considerations, data handling, acceptable and unacceptable file types).
• Data editing, cleaning and / line of sight related to all data types including commercial implications where applicable.
• CDM process for clinical data cleaning and quality framework.
• Source data policy definition against received and generated data.
• Patient Identifiable Information (PII) and data privacy.
• Standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulations.
• Definition and implementation of standards relating to data storage and retrieval of data.

Define / implement standard approaches for eClinical systems integrations, data transfers and data outputs (e.g., reports, exports) including:

• Integrations / data transfers between eClinical systems (e.g., IRT, eCOA, EDC, CTMS, CDMS) with optimal performance and support.
• Standard suite of data transfers.
• Complex Innovative Designs (e.g., Master Protocols, Covariate Adaptive Randomization, Adaptive Designs, Custom Algorithms).
• Randomization data (e.g., client / external access during live study (e.g. DMC / drug safety reviews), policies / procedures on delivery / access / transfer (i.e., what, when, how)).
• Stakeholder specific data where applicable (i.e., medication management related data for Clinical Supplies Manager; Randomization data for Biostatistician).
• eCOA data including any requirements / best practices for use of validated instruments used for endpoints.
• For use by Almac stakeholders for the conduct and support of studies (e.g., for internal health‑check reviews).
• For use in support of Electronic data regulatory submissions (following CDISC, ADAM, SDTM standards / formatting).

Acts as a lead owner across relevant projects and initiatives.

• Champion technology improvements / tools related to CDM processes.
• Provide direct support and guidance to internal stakeholders for CDM policies and procedures across key areas (e.g., support, data services, biostatistics, QA).
• Promotes and leads standardization, automation, innovation, implementing policies, clinical data standards and process improvement, and technology enhancement in CDM.
• Identify / evaluate issues, provide strategy and direction for functional areas, and lead the effort for improvement / optimization of CDM.
• Identifies opportunities for the business to monitor compliance to established procedures and mitigate risk.
• Build strong relationships with key cross‑functional stakeholders acting as CDM Subject matter expert.
• Develops implementation and operational processes for system implementation and data governance at the R&D level.

Business Continuity and Development:

• Managing relationship with eClinical Vendors.
• Input into feature or product development that allows for visibility & portability of the eClinical product data set at the investigator level.
• Ensures the business is in alignment with evolving policy, objectives, industry trends, and regulatory guidance.
• Interacts with clients to consult, manage issues, prepare for new business and maintain relationships.

Additional Functions:

• Support business development efforts with RFP and client presentation planning and execution.
• As…