Senior Clinical Programmer

Senior Clinical Programmer

Perfect time to be a part of a established and growing biotech company as a Sr Clinical Programmer.


Responsible for performing the clinical systems activities for the entire life cycle of one or more clinical trials, from protocol concept review through completion of the Clinical Study Report (CSR). The position collaborates with the CDA, Stat Programmer and other members of the Study Management Team to develop a study database consistent with needs of the study protocol and consistent with department standards and procedures. The position also mentors less experienced staff; manages complex trials and partnerships; and acts as lead or consultant on special initiatives both inside and outside the Data Management department.


Responsible for developing the study database as specified by the study protocol and study CRF in collaboration with the study CSA, study Stat Programmer and other members of the Study Management Team.

Responsible for communicating with external data providers and for defining the data transfer specifications.

Responsible for loading the electronic data as specified by the study protocol.

Responsible for the delivery of the data to Stat Programming for programming and analysis within the timelines established by the Study Management Team.

Act as a lead or functional area consultant on process improvement initiatives, special initiatives and capability projects both inside and outside the Data Management department.

Conduct peer review and QC deliverables from internal & external employees, including but not limited to: annotated CRFs, database builds, and electronic data load specifications

Provide input to managers regarding resource allocation and priority setting

Contribute to the evolution of department standards, work instructions and best practices through participation in continuous improvement initiatives to further develop the in-house center of excellence.

Provide metrics on milestone achievement and participate in the improvements to quality and efficiency.


Qualifications Minimum of 5 years clinical systems experience working in the biotechnology or pharmaceutical industry; work with CROs highly desirable

Education: BS/BA or equivalent in a discipline related to Clinical Data Management Systems

Expertise with Oracle Clinical or other clinical data management software A MUST; familiarity with medical coding dictionaries, especially MedDRA and WHO. General software skills: Lotus Notes, MS Access, MS Word, MS Excel, MS Project, Visio, Business Objects, SQL

Experience applying best practices in application development to the clinical trial evironment, including requirements definition and QC plans

Aware of current global regulatory guidelines relevant to Clinical Data Management, as well as related Pharma Development SOPs, guidelines and Best Practices In-depth knowledge and understanding of the drug development process and data management process.

Knowledge of GCP and other regulations

Excellent multi-level, oral and written communication skills. Ability to manage multiple projects and processes simultaneously.

Internal customer management, influence of peers, team effectiveness and enhancement, timeline management, proactive problem solving ability, ability to develop trust, shared goals and values.

Collaborative, with negotiation skills, conceptual thinking, systems process thinking, accountability to deliverables milestones, conflict resolution (internal and external).

Must have excellent oral and written communication / presentation / negotiation skills.

Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.

Ability to handle multiple (changing) priorities under tight timelines

Ability to work well in a fast-paced environment.
Education BS/BA or equivalent in a discipline related to Clinical Data Management Systems