Senior Clinical Programmer

Propharma

5+ years

Not Disclosed

United Kingdom

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: BS/**Rewritten Job Description:** **Position Title:** Senior Clinical Programmer **Location:** United Kingdom **Employment Type:** Full-Time **Posted:** B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Rewritten Job Description:

Position Title: Senior Clinical Programmer
Location: United Kingdom
Employment Type: Full-Time
Posted: 6 Days Ago
Job Requisition ID: JR 6501

About ProPharma:
For over 20 years, ProPharma has empowered biotech, med device, and pharmaceutical organizations to drive scientific breakthroughs and deliver new therapies. As the world’s largest Research Consulting Organization (RCO), we support clients throughout the product lifecycle with our advisory, build, and operate model. Our deep expertise in regulatory sciences, clinical research, pharmacovigilance, medical information, and R&D technology enables us to offer customized solutions that accelerate drug and device programs.

Position Overview:
ProPharma is seeking a Senior Clinical Programmer to take the lead on multiple studies for a client FSP (Functional Service Provider). This role involves providing clinical programming expertise, supporting the design and development of clinical databases, and ensuring that all systems and databases meet regulatory standards.

Key Responsibilities:

Act as the Lead Clinical Programmer for one or more studies for a client FSP.
Complete clinical programming tasks for assigned studies, adhering to the study contract, SOPs, and applicable regulations.
Design, develop, implement, maintain, and support clinical database systems.
Provide technical expertise to both internal and external clients.
Program, test, and document databases according to programming standards and clinical validation policies.
Perform database manipulation and conduct data transfers for clients.
Review Data Validation Plans and Case Report Forms (CRFs) for assigned areas of expertise.
Integrate external data sources (e.g., PK and central lab data) into the clinical database if integration is required.
Serve as the programming point of contact for database issues within the area of expertise.
Support the development and implementation of new technologies and participate in software change controls.
Contribute to the revision and maintenance of core operating procedures and working instructions related to database development, user acceptance testing, and change controls.
Organize responsibilities and deliverables by coordinating with the project team.
Build effective communication and professional relationships with both internal teams and external vendors.
Coordinate with Clinical Data Management and corporate teams to negotiate timelines and deliverables.
Perform administrative tasks within the EDC system (e.g., site/user management, URL level reviews/approvals, dictionary updates).
Influence the development of data standards and strategies related to the standards library.

Required Skills & Qualifications:

RAVE certification is advantageous; however, applicants with strong knowledge of RAVE principles will be considered.
Solid understanding of ICH GCP and regulatory requirements is essential.
Strong organizational and analytical skills.
Excellent written and oral communication skills.
Ability to work in a high-paced, timeline-driven environment.

Educational Requirements:

Minimum of a BS in a scientific or health-related field, or equivalent experience.

Experience Requirements:

Minimum of 5 years of experience as a clinical database developer.
At least one year of experience leading a study build.

Additional Information:
At ProPharma, we are committed to diversity, equity, and inclusion. We strive to create a workplace where every employee feels empowered to succeed. We encourage innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe space where all employees can thrive.

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Senior Clinical Programmer

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