Principal Database Programmer

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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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c0qwl