Senior Clinical Data Manager

Senior Clinical Data Manager

OPIS

Desio, Italy

The Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.

Some of what you'll do:

• Ensure data is managed in compliance with applicable standards (e.g., CDISC), regulatory guidelines and OPIS SOPs;
• Prepare/validate Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.);
• Design/validate the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team;
• Prepare/validate the eCRF/clinical databases and related tools;
• Prepare and manage change request of database;
• Perform data cleaning activities;
• Perform coding activities of medications and medical terms using medical dictionaries;
• Perform SAE reconciliation when required;
• Manage database lock and freeze before data analysis;
• Prepare, maintain, and archive data management documentation;
• Perform quality controls according to the Data Management Plan;
• Participate in study specific audit/inspection;
• Liaise with Sponsor and external stakeholders regarding data management activities;
• Escalate potential risks/issues to Direct Manager;
• Track activities and milestones to ensure timely project deliverables;
• Participate to meetings, kick-off meeting and teleconferences for assigned projects Organize/perform trainings for project team - Collaborate in establishing and maintaining SOPs related to Data Management;
• Collaborate in establishing and maintaining document/programming standards;
• Promote the introduction of digital technologies and innovative data processing tools and acts as a mentor for junior staff;
• Ensure that KPI and metrics for the assigned studies are met;
• Perform and complete on time all required trainings (study trainings, training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due date;
• Ensure daily completion of TRACK system, correct entry of appropriate billable and non-billable time;
• Perform other tasks as assigned.

What we're looking for:

• Bachelor’s degree;
• At least 4 years of experience in CRO, biotech, pharma, research institutes or 3 years in similar role;
• Solid knowledge of ICH-GCP/ISO14155, clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data Management;
• Digital skills and good knowledge of FDA 21 CFR Part 11 and system validation;
• Solid knowledge on relational databases and programming languages;
• Knowledge of CDISC standard specifications;
• Knowledge of SAS system is a plus;
• Excellent knowledge about Microsoft package;
• Strong commitment to quality;
• Flexibility and propensity for innovation;
• English language (fluent reading, writing and verbal skills);
• Planning and organizational skills;
• Communication skills;
• Result-oriented;
• Team-working oriented.