Principal, eClinical Data Management Location: Craigavon Hours: 37.5 Hours Per Week Salary: Competitive Business Unit: Clinical Technologies Open To: Internal and External Applicants Ref No.: HRJOB10534 The Role The Principal, eClinical Data Management role is responsible for the development of standards for data management, integration and reporting in support of Almac Clinical Technologies products and services for clinical trials to ensure conformance to regulatory / industry best practices. The successful candidate will ensure that high quality data is obtained, processed, shared, managed and/or reported to Sponsors or third parties. Responsibilities include: Developing eClinical Data Management (CDM) policies / procedures Defining / implementing standard approaches for eClinical systems integrations, data transfers and data outputs (e.g., reports, exports) Leading relevant projects and initiatives (e.g., eClinical product / process improvements, risk mitigation) Ensuring Business Continuity and Development related to eClinical products / services. What we are looking for Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up permanent employment in the UK Degree level (or equivalent) Significant experience in clinical data management or a similar role in pharmaceutical or clinical research industry. Experience with various e-clinical technologies /software systems. o Preferably with IRT and eCOA systems Significant experience communicating directly with clients. Related work experience in eClinical, pharmaceutical, biotech, or medical device industry/company. Demonstrable knowledge of: 1. Clinical data management processes and best practices 2. FDA 21 CFR Part 11 as it relates to software solutions. 3. Data privacy and protection regulations (e.g., GDPR, PII). 4. Clinical trial design and knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). 5. Knowledge of industry-standard data analysis and reporting software (e.g., SAS and/or SQL). Further Information For further information on essential and desirable criteria, please review the job description attached to the online job posting. Apply Now Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible. Closing Date We will no longer be accepting applications after 5pm on Tuesday 8 April. RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Skills: Clinical Trials Data Management Process Improvement Pharmaceutical products Benefits: Attractive Compensation Package Relocation Assistance Lunch & Learns Employee Recognition Employee Referral Bonus Death in Service Pension Scheme