Senior clinical data manager
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
Who we are:
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.
What we offer:
We offer a competitive salary with other benefits / bonuses and opportunity to develop your professional career with an expanding and growing company.
Please read the information notice on the processing of personal data in the candidates information section of our company website.