Principal Database Programmer

Responsibilities

• Accountable for driving achievement of project milestones from study start‑up through to delivery of the database and monitoring of time spent on tasks.
• Provide Database Programming input into protocol data collection assessments.
• Create the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance with relevant company procedures.
• Accountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF.
• Develop the computerized checks in accordance with the Data Validation Plan.
• Develop SAS checks in accordance with the Data Validation Plan.
• Implement mid‑study changes to the production eCRF when requested by the Lead DM.
• Communicate the database setup status and the achievement of milestones to the Lead DM.
• Create and validate import programs of electronic data received from external vendors.
• Import electronic data received from external vendors during the course of the clinical study.
• Program and validate data listings (e.g., Manual checks, Medical Review listings, Coding report, etc.).
• Program and validate tracking or metric reports.
• Plan and prioritise work and take appropriate actions (e.g., escalation).
• Contribute in formal training for new database programming staff.
• Apply SOPs and guidance documents as well as applicable industry standards such as ICH, GCP, etc. to day‑to‑day activities and generate all required documentation for study files.
• Lead the DBP team, coordinate other DBP staff, provide direction regarding work assignment, scheduling and prioritizing, and monitor progress of activities.
• Maintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues.
• Develop and maintain a network of contacts within the study team.
• Make recommendations for database setup process improvements and development of new standards.
• Input into and monitor progress against study project plan and escalates issues to resolution at the appropriate level.
• Prove ability to analyse data capture problems/opportunities and deliver high‑quality solutions.
• Demonstrate broad and integrated knowledge of all aspects of Database Programming, providing consultancy to other groups outside DBP.
• Educate/train on use of study‑specific data collection tool(s).
• Represent Database Programming in internal or external meetings (e.g., EDC demos).
• Conduct other activities as required.

Qualifications

• Degree (preferably in Computer Science) or at least 6 years of experience in database programming or a similar role within a pharmaceutical environment or equivalent.
• Knowledge of Alira Health systems.
• Very good knowledge of Data Management processes and pharmaceutical industry guidelines such as ICH, GCP, etc.
• Expert knowledge in one or more clinical data management systems and recognized for expertise (e.g., Medidata Rave, Merative Zelta).
• Knowledge of SAS programming.

Desired Qualifications & Experience

• Expert on Merative Zelta build and/or Medidata Rave build; certification of study builder is an added value.

Technical Competences & Soft Skills

• English language proficiency.
• Good MS Office Suite skills.
• Professional trustworthiness.
• Ability to effectively prioritize.
• Quality focus.
• Personable attitude.
• Willingness to learn.
• Team player.
• Effective stress management techniques.
• Learning agility.
• Conflict management.
• Problem‑solving skills.
• Effective verbal communication.
• Commercial and technical writing.
• Networking skills.
• Analytical thinking.
• Resilience.
• Ability to influence and motivate.
• Rapid conflict resolution.
• Innovation.
• Constructive feedback.
• Excellent presentation skills.
• Commercial awareness.
• Talent development.

Languages

• English

Contract Type

• Hourly