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Lead Data Manager for Clinical Trials

PSI CRO -
Buenos Aires, Buenos Aires

Postulación rápida

Detalles del empleo

Tiempo completo

Descripción completa del empleo

Company Description

We’re over 2,700+ strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

Job Description

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.

Communication

Primary communication point for project teams and company departments with regard to clinical data management
Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting

Data Management

Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
- Study documents review
- Data Management plan and other project-specific guidelines and instructions development and review
- Co-ordinate/perform user acceptance testing
- Development of Data Validation Plan/Edit Check Specifications
- Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
- Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
- Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
- Database edits (paper CRF studies)
- Manual CRF review (non-medical checks)
- Clinical database lock
- Coordination and supervision of processing, dispatch and archiving of CRFs/queries
Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
Development of CRF completion guidelines
Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
SAE reconciliation
Electronic data transfer (import/export) specifications review and approval

Document Management

Liaison with Document Center with regard to maintenance of TMF and eTMF

Quality Control

Database QC checks performance and documentation
Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management

Training

Training of Assistant Data Managers
Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments

Investigator Meetings preparation/attendance
Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications

College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
At least 3 years of experience of full scope of data management responsibilities in international EDC studies
At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
Project data management experience is a plus
Full working proficiency in English
Organizational and managerial skills

Additional Information

Advance your career in clinical research and develop new skillsets whilst growing with the organization.

Postulación rápida

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