Senior Data Manager Lazio

Senior Data Manager
Roma
Lazio, Lazio

Our client, one of the top 5 pharmaceutical companies in Italy, is looking for a Senior Data Manager.

Dettagli sul cliente

Our client, one of the top 5 pharmaceutical companies in Italy, is looking for a Senior Data Manager.

Descrizione

Role:

- Responsible for all trial/project level data management activities, starting from CRF design and data base (DB) set-up to DB lock.

**Responsibilities**:

- Coordinate and supervise Contract Research Organization (CRO) activities.

- Ensure proper and timely CRF design as per established standards and applicable protocol.

- Ensure proper and timely build and validation of clinical database.

- Ensure proper implementation of CDISC standards.

- Develop/review requirements of edit checks to guarantee high quality data.

- Ensure proper and timely programming and validation of edit checks.

- Prepare/review, maintain and archive data management documentation.

- Guarantee that user acceptance testing, data transfer requirements and deployment of clinical trial sites are well defined.

- Develop/review reports/listings to support medical monitoring.

- Generate (or supervise generation of) data queries based on eCRF review and validation checks.

- Ensure proper planning of DB lock activities, final data transfer and high quality data.

- In case of insourcing of DM tasks, be responsible for all DM activities, starting from CRF design, to DB lock and final data transfer, ensuring timely delivery and high quality data.

- Prepare/ensure appropriate formatting to datasets as requested.

- Collaborate in the CRO selection process and attend BID defense meetings

- Provide guidance/training and support on the use of electronic tools, such as Electronic Data Capture Systems, or Interactive Response Technology, etc.

- Develop or select specific software programs for various research scenarios.

- Write/review work instruction manuals, data capture guidelines, or standard operating procedures (SOPs).

- Collaborate with Clinical Trial Team in the preparation of protocols, clinical study reports, regulatory submissions, or other controlled documentation.

- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.

- Collaborate with Clinical Trial Team in ensuring clinical trial is in inspection ready status;

- Monitor work productivity or quality to ensure compliance with SOPs and key performance indexes.

- Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.

- Develop project-specific data management plans that address areas such as data coding, reporting, or transfer, database locks, and work flow processes.

- Ensure proper qualification and training records according to the job requirements are available

- Consistently comply with all governing laws, regulations, Alfasigma SOPs and other guidelines.

- Ensure proper support for the development/improvement of internal processes, standards and SOPs applicable for the R&D Function and related activities.

- Collaborate in hiring and on-boarding of new associates and act as a mentor for junior staff.

Profilo del Candidato

Qualifications:

- BS/BA in a scientific or programming discipline

- Minimum of 5 years of experience in clinical data management.

- Experience in a regulatory environment within biopharmaceutical product development.

- Extensive knowledge of clinical development process, regulatory requirements and Good Clinical Practice (GCP).

- Expert knowledge of EDC processes and systems, database structures and available tools to manage, extract, and report data.

- Knowledge of programming languages (e. g.

SAS, SQL)

- Expert knowledge of CDISC (CDASH and SDTM) standards

- Experience managing multiple complex global studies

- Ability to work independently and collaboratively with colleagues and project leads.

- Considerable organizational awareness, including significant experience in matrix and high-pressure environments

- Excellent written and oral communication skills.

- Exceptional organizational and problem-solving skills.

- Demonstrated excellent project management and leadership skills.

- Proven networking skills and ability to share knowledge and experience amongst colleagues.

- Fluent English (oral and written).

offerta di lavoro

Great opportunity