Senior Data Manager BOLOGNA

Senior Data Manager
Bologna
Emilia Romagna, BOLOGNA

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 delivers a quality database in accordance with the project plan, leads and drives 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.

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 delivers a quality database in accordance with the project plan, leads and drives 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.

For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF.

For EDC studies, timely response to issues identified by the eCRF 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 the 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.

Maintain continuous and appropriate communication with sponsor and share with them critical and general issues.

Effectively represent 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 3 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 etc.

Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent.

Knowledge in one or more DM systems.

TECHNICAL COMPETENCES & SOFT SKILLS

English.

MS Office Suite.

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

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

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