Senior Data Manager

Alira Health

Verona

EUR 70.000 - 90.000

Descrizione del lavoro

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 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

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 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