Data Manager/Clinical Research Associate

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/CRA 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:

• 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 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.

As a Clinical Research Associate (CRA), you will:

• Conduct on-site monitoring visits, upholding compliance with study protocols, Good Clinical Practice (GCP), and applicable regulations.
• Act as a pivotal communication conduit between study sites and the project team, managing data collection and ensuring precise data reporting.
• Proactively address potential issues, facilitating effective communication between site staff and the project team.

About you

To thrive in this role, you are someone who has a background in data management within the clinical development field of the medical device or IVD industry. While not necessarily looking for a senior level, we expect you to have experience managing DM activities within a clinical study. You have a keen eye for detail, a commitment to data quality, and the ability to oversee eCRF design with vendors.

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 DM/CRA 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

Key Responsibilities for Data Manager:

Study Set-Up:

• eCRF Design Oversight: work with vendors to ensure 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 Data Management Plans (DMPs), 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.

Key Responsibilities for Clinical Research Associate:

Study Set-Up:

• Site Selection and Preparation: assist in the selection of study sites and prepare them for study initiation, including the training of site personnel on study-specific data collection procedures as related to DM requirements.
• Contribute to the development of Monitoring plans and other essential documents
• Regulatory Compliance: Ensure all study sites are aware of and adhere to data management regulations and expectations from the outset.

Study Conduct:

• Site Monitoring: conduct regular monitoring visits to assess the quality of the data produced, verify source document accuracy, and ensure compliance with the study protocol.
• Effective Communication: serve as a bridge between the site personnel and the project team team, ensuring any data-related issues are resolved promptly and effectively.

Study Closure:

• Data Verification: ensure that all data-related tasks at the study sites are completed and that the data is ready for lock and analysis.
• Close-Out Visits: Conduct site close-out visits to confirm that all data-related obligations have been met and to discuss the outcome of data management activities with site personnel.

There is flexibility in the role depending on your interest and wish for continued professional learning.

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 1 year of experience in a data management role
• At least 1 year of experience in the monitoring of clinical investigations for medical devices and in vitro diagnostic devices Familiarity with Good Clinical Practice such as ISO 14155 and ISO 20916
• and regulatory standards pertaining to medical devices and in vitro diagnostic devices
• 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

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!

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