Senior Clinical Data Manager

OPIS; Desio; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization is seeking a Senior Data Manager in Desio, Italy. You'll oversee the management of clinical data ensuring compliance with relevant standards. The ideal candidate has a Bachelor’s degree, at least 4 years of experience in the field, and strong digital skills. This role offers a competitive salary and opportunities for professional development.

Servizi

Competitive salary

Opportunities for professional development

Benefits and bonuses

Competenze

• At least 4 years of experience in CRO, biotech, pharma, or research institutes.
• Solid knowledge of ICH-GCP / ISO14155 and data management standards.
• Knowledge of CDISC standard specifications.

Mansioni

• Ensure data is managed in compliance with applicable standards.
• Prepare and validate data management documentation.
• Perform data cleaning activities and coding of medications.

Conoscenze

ICH-GCP knowledge

Clinical data management

Programming languages knowledge

Digital skills

Microsoft package proficiency

Communication skills

Planning and organizational skills

Result-oriented mindset

Team-working oriented

English (fluent)

Formazione

Bachelor’s degree

Strumenti

SAS system

Descrizione del lavoro

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.