Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients.
Skills and attributes
* Clinical Trials
* Data Management
* Process Improvement
* Pharmaceutical products
Description
Principal, eClinical Data Management
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:
1. Developing eClinical Data Management (CDM) policies / procedures
2. Defining / implementing standard approaches for eClinical systems integrations, data transfers and data outputs (e.g., reports, exports)
3. Leading relevant projects and initiatives (e.g., eClinical product / process improvements, risk mitigation)
4. 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, 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.
Paid Time-Off for Vacation and Sick Days
Almac Group is an Equal Opportunity Employer
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