Data Manager

Clinical development
Göteborg, Lund, Stockholm
Flexible remote working

Key2Compliance MedTech Contract Research Organization (CRO) is known for our meticulous approach to clinical evaluations, strategizing clinical pathways, designing studies, and executing clinical investigations. With a growing team that includes Clinical Project Managers, biostatisticians, data managers, and Clinical Research Associates, we’re now looking to bring on board a proactive Data Manager to join our ranks. You will be joining a team that is at the forefront of medical device and IVD development, helping to drive our mission of advancing healthcare through clinical development practices.

About the role

As a Data Manager, you will:

  • Participate and give input in study design
  •  Oversee the design process carried out by vendors to ensure the eCRF is developed according to the study plan and effectively captures the required data.
  • Develop the Data Managent Plan and other documents related to data management.
  • Review eCRFs during the design phase and prior to implementation, confirming that they meet all study requirements and maintain data integrity.
  • Monitor the data management lifecycle, from data collection to data lock, ensuring data accuracy and consistency.
  • Collaborate with the project team for database setup, data validation, and query resolution processes, while ensuring the timely delivery of datasets for analysis.
  • Manage eCRF User Training sessions.
  • Take part in the development of Data Management SOPs and templates.

About you

We are seeking a Data Management (DM) professional with solid experience in the clinical development sector, specifically within the medical device or IVD industry. The ideal candidate will have been involved in the study design phase, offering insights into data management considerations for developing study plans. Your experience should include managing DM activities through the various phases of a clinical study, with a focus on maintaining high data quality. In addition, you should be comfortable overseeing eCRF designs in collaboration with vendors. We value meticulous attention to detail and a proven track record of managing DM tasks effectively.

Your collaborative skills will shine as you work with cross-functional teams to ensure data collection methods are robust and regulatory compliant. Your proficiency in both Swedish and English will be essential as you communicate with diverse stakeholders and document processes.

We are looking for a Data Manager ready to engage in a role where their actions significantly impact the quality and outcomes of our projects. If you’re prepared to take on the challenges and rewards that come with being part of a leading MedTech CRO, we would love to hear from you.

Key Responsibilities

Study Set-Up:

  • eCRF Design Oversight: work with vendors to ensure that eCRF designs are aligned with the clinical study plan, are capable of capturing the necessary data, and meet all regulatory and protocol-specific requirements.
  • Study Documentation Review: participate in development or development and finalizing study documentation, such as a Data Management Plan (DMP), ensuring thoroughness and adherence to Good Clinical Practice (GCP) and other regulatory standards.

Study Conduct:

  • Data Management Activities: manage the collection, processing, and quality checking of study data to ensure consistency, accuracy, and integrity.
  • Data Oversight: Monitor the data flow throughout the study, including query management, interim analysis preparations, and ongoing data validation.

Study Closure:

  • Database Lock Preparation: coordinate activities related to database lock, including final data cleaning, query resolution, and ensuring all data is audit ready.
  • Final Data Review and Reporting: Contribute to the preparation of final datasets, ensure that all data management activities are thoroughly documented and that study databases are closed according to SOPs and regulations.

Qualifications

Education Requirements/Certifications

  • Bachelor’s degree in a relevant field or equivalent practical experience

Required Knowledge/Skill

  • Solid understanding of Good Clinical Practice for medical devices and in vitro diagnostic devices.
  • Good knowledge of clinical investigation requirements under MDR 2017/745 and IVDR 2017/746, along with a well-rounded familiarity with related regulatory guidelines.
  • At least 2 year of experience in a data management role.
  • Experience with eCRF design oversight and review.
  • Professional communication skills in English and Swedish.
  • Proactive, solution-oriented, and adaptable.

Information and contact details

Place of employment: Stockholm, Lund or Gothenburg

Scope: Full time

Questions: Please contact Director Clinical Development, Jeanette Demorney, jeanette.demorney@key2compliance.com

Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.

We look forward to receiving your application!

Read more about us here →

Are you interested in Key2Compliance but you don’t feel that this position is the perfect match?
Check out our other open positions here →

Do you know any who would be even better suited?

Tell them.

Search

Send application

Cookies

For your best experience are we using cookies on this website.