Senior Data Manager

1 settimana fa

Verona, Italia Alira Health A tempo pieno

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration.

Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective Job Description ROLE The Senior Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.

KEY RESPONSABILITIES Accountable for driving achievements of project milestones from study start up through to delivery of database Provide Data Management input into the protocol Design the Case Record Form and guide process for CRF approval Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g.

Reconciliation Plan), with input from the study team Validation of the database and computerized checks, including SAS listings or SAS checks Validation of the database and computerized checks, including SAS listings or SAS checks For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality e CRF For EDC studies timely response to issues identified by the e CRF Helpdesk Prepare CRF completion guidelines Prepare study specific data-entry guidelines and train data-entry staff Perform term coding for clinical studies, raise manual queries for uncoded terms as required Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings Create and test import programs for electronic data received from external vendors Perform timely data integration of CRF and non CRF data (data import from external sources) Perform reconciliation of external data (e.g.

SAE, Central Labs, ECGs, etc) Run and monitor study data progress reports including query management and take appropriate actions (e.g.

escalation, re-training, etc), escalate any study issues within study team Define and execute QC plan, lead and execute database release and database freeze activities Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level Effectively contribute in formal training for new starters Demonstrate good application of document management process and procedures Follow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities Make recommendations for process improvements and development of new standards Develop and maintain a network of contacts within the study team Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities Maintain continuous and appropriate communication with sponsor and share with them critical and general issues Effectively represents Data Management in internal or external meetings (e.g.

Investigator's Meetings) Conduct other activities as required DESIRED QUALIFICATION & EXPERIENCE Degree in life science, pharmaceutical, biology or related field or at least 5 years' experience in data management field or similar in a pharmaceutical environment or equivalent Knowledge of Data Management processes Knowledge of pharmaceutical industry guidelines like ICH, GCP Experience in oncology studies, with focus on early phase oncology studies Knowledge of Medidata RAVE EDC, Proficient TECHNICAL COMPETENCES & SOFT SKILLS English, Good MS Office Suite, Good Professional Trustworthy Ability to effectively prioritize Quality focused Personable Attitude Willingness to learn Team Player Effective Stress Management Techniques Learning Agility Ability to Manage Conflict Problem Solving Skills Effective Verbal Communication Skills Commercial and Technical Writing Skills Networking Skills Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy Contract Type Regular #J-18808-Ljbffr

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