Job Description

About the role:

Senior Clinical Data Associate -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.

Minimum Qualifications & Experience:

• Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.

• At least 2-4 years' experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role.

Responsibilities:

Member of theprojectteamreportingtotheBiometricsProjectManageronprojects,the SeniorClinicalDataAssociateisresponsibleforindependently providingaccuratedata acquisition, data validation,reconciliationandmentoringthe juniorstafftothe clinical studies and shallensurequalitystandards per SOPs andICH-GCP

• Performcomprehensivedatamanagementtasksincluding datareview,query management, external data reconciliation.

• Tracking ofCRF pages (or otherstudydatadocuments) receivedandentered; tracking ofdataqueriesreceived;proactivemetricreporting ofCRFpages(orother studydata documents) received andentered to studyteam members

• Prepareand validate databasespecification and editchecks specification procedures

• AccurateandtimelyfilingofCRFs(orotherstudydatadocuments),DCFs,orother

• DM related documents (egData Management Plan, Self-Evident Corrections).

• Accurate and timelyarchivingof studyDMF, CRF Files,and DataQueryMaster File.

• PerformuseracceptancetestingofDataEntryScreen andconsistencechecksof

• Clinical StudyDatabases as required.

• Mentor junior CDAstaffas required.

• RepresentDataManagementTeamonallCDArelatedmatters,bothinternallyand externallyegInvestigator meetings,audits etc.

• SupportCDM withCDM role activities whereappropriate.

• Can act as internal DMLead on studies, reporting to CDM/SCDM on astudylevel.

• Liaison with external serviceproviders onData Management projects as appropriate.

• Proactiveparticipation in project meetings as requested byCDM.

• Prepare agendaminute writing for data management team meetings; be the lead/facilitatoronCDA-relatedtopics/discussionincluding preparing topic presentations, and being CDAsubject matter expert.

• ProvidegeneraladminandprojectmanagementsupporttoDataManagementTeam as required.

• AdherencetocompanyQualityPolicyandproceduresasapplicabletocarryingout jobresponsibilities;awarenessofotherstudy teamroleproceduresandhowthey interactaffect CDArole.

• Proactive contributiontocompany process improvementinitiativesasrequired; identify opportunities forimprovementswiththeDM Team; lead CDA related process improvements.

• Understand the responsibilities of Novotech as a service provider in the pharmaceuticalindustryandensureallcommunicationswithexternalpartiespresent apositiveprofessional imageof thecompany.

• Participation in industryfora(conferences, professional associations etc)as ameans

• of professional development as wellas promotionof Novotech’s imagein industry

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working in clinical research and biotech, including people who identify with LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to talking to you about working at Novotech.

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.