Job Description

Responsible for day-to-day data processing operations for data management projects, including CRF (or other study data document) tracking, entry, and filing. Provides administrative and project management support to CDMs for data management projects as required, including creation and maintenance of project files. Support and mentor junior staff members. Conducts all responsible activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Responsibilities

Member of the project team reporting to the Biometrics Project Manager on projects, the Senior Clinical Data Associate is responsible for independently providing accurate data acquisition, data validation, reconciliation and mentoring the junior staff to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.

• Perform comprehensive data management tasks including data review, query management, external data reconciliation.
• Tracking of CRF pages (or other study data documents) received and entered; tracking of data queries received; proactive metric reporting of CRF pages (or other study data documents) received and entered to study team members.
• Prepare and validate database specification and edit checks specification procedures.
• Accurate and timely filing of CRFs (or other study data documents), DCFs, or other.
• DM related documents (eg. Data Management Plan, Self-Evident Corrections);
• Accurate and timely archiving of study DMF, CRF Files, and Data Query Master File.
• Perform user acceptance testing of Data Entry Screen and consistence checks of Clinical Study Databases as required.
• Mentor junior CDA staff as required.
• Represent Data Management Team on all CDA related matters, both internally and externally e.g. Investigator meetings, audits etc.
• Support CDM with CDM role activities where appropriate.
• Can act as internal DM Lead on studies, reporting to CDM/SCDM on a study level.
• Liaison with external service providers on Data Management projects as appropriate.
• Proactive participation in project meetings as requested by CDM.
• Prepare agenda/minute writing for data management team meetings; be the lead/facilitator on CDA-related topics/discussion including preparing topic presentations, and being CDA subject matter expert.
• Provide general admin and project management support to Data Management Team as required.
• Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities; awareness of other study team role procedures and how they interact/affect CDA role.
• Proactive contribution to company process improvement initiatives as required; identify opportunities for improvements with the DM Team; lead CDA related process improvements.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
• Participation in industry fora (conferences, professional associations etc) as a means.
  of professional development as well as promotion of Novotech’s image in the industry.

Minimum Qualifications & Experience

• Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.
• At least two to four years experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role.