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.
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.
- 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).
- 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.
- 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.
- Assist with client adoption and migration consulting, recommendations and implementation. Support client assessments with key stakeholders to elicit and review business requirements.
Behavioral Requirements:
- The incumbent must possess technical aptitude and the ability to analyze complex problems and provide guidance on problem resolution.
- Handling multiple responsibilities and job tasks (multi-tasking) as needed.
- Balancing attention to detail with delegation skills to empower employees to make good decisions and achieve desired results.
- Flexibility with work requirements, work environment, and fast-paced/changing job needs.
- Superior communication skills including the ability to present ideas, analysis, and feedback to all levels of the organization and in group settings and one on one.
- Ability to motivate and engage staff to provide a cohesive and well-functioning team.
- Ability to work with other team disciplines to collaborate on what is best for the business overall and not just on what is best for the individual team.
- Ability to solicit feedback from internal and external stakeholders and develop common understanding of business problems to drive effective solutions
Required Education
- Bachelor’s Degree in scientific or healthcare-related field
Preferred Education:
- Masters preferred
Required Work Experience:
- 7+ years of experience communicating directly with clients
- 7+ years of clinical data management or a similar role in pharmaceutical or clinical research industry.
- Experience with various e-clinical technologies/software systems
- Related work experience in eClinical, pharmaceutical, biotech, or medical device industry/company.
Preferred Experience:
- Experience with IRT systems
- Experience with eCOA systems (including handling data of validated instruments used for endpoints)
Required Knowledge:
- Clinical data management processes and best practices
- Broad understanding of overall drug development process, clinical trials through all phases.
- Understanding of clinical trial design, biostatistical and supply management applications
- Understanding of FDA 21 CFR Part 11 as it relates to software solutions.
- Understanding of data privacy and protection regulations (e.g., GDPR, PII).
- Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- Knowledge of industry-standard data analysis and reporting software (e.g., SAS and/or SQL).
Preferred Knowledge:
- Understanding of various e-clinical technologies/software, specifically Interactive Response Technology products and eCOAs (electronic clinical outcomes assessments)
- Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
Skills:
- Strong communication skills (written and verbal)
- Strong customer service skills
- Strong ability to fostering and promoting teamwork
- Prior management and / or leadership experience
- Ability to work independently, motivated to take initiative
- Effective combination of people skills and assertiveness
- Strong organizational skills
- Ability to perform multiple project tasks
- Experience facilitating customer interactions and understanding of customer pains / needs
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