Clinical Project Manager/Clinical Research Associate

Clinical Project Manager/Clinical Research Associate

Welcome to Key2Compliance and our dedicated MedTech Contract Research Organization (CRO) powered by a team of 20 passionate consultants. Our expertise lies in assisting clients with clinical evaluations, strategizing clinical pathways, designing studies, and executing clinical investigations. We are proud to have in-house Clinical Project Managers (CPMs), biostatisticians, data managers (DMs), Clinical Research Associates (CRAs), and experts in clinical evaluation and medical writing. Serving primarily small to medium-sized medical device and in vitro diagnostic (IVD) companies, we have established a strong presence in Scandinavia and are expanding our reach across Europe. At Key2Compliance, we’re committed to advancing medical technology and IVD development through our comprehensive, client-focused services.

Our team is expanding, and we need an experienced CPM/CRA to join us in meeting our clients’ needs at Key2Compliance. Your skills will be an integral part of what we offer our customers.

About the role

We are seeking an experienced Clinical Project Manager (CPM) and Clinical Research Associate (CRA) within MedTech to be a vital part of our team. This dual-role position is centered in our Clinical Operations division.

As a Clinical Project Manager, you will:

• Lead clinical projects from conceptual study design through to practical implementation.
• Monitor all project facets including progress, budget, schedule, and resource allocation.
• Provide expert advice and guidance to clients based on current regulations, standards, and guidelines, leveraging your deep industry know-how to navigate the complex regulatory landscape effectively.
• Ensure adherence to protocols and regulatory requirements, maintaining the highest standards of quality and safety.

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

• Conduct on-site monitoring visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulations.
• Serve as the key communication link between the study site and the project team, managing data collection, and ensuring accurate data reporting.
• Address potential issues promptly, facilitating effective communication between site staff and the project team.

Beyond clinical investigations, we offer our clients robust support throughout the evaluation process, including reports for regulatory submissions and managing inquiries from notified bodies. In your role, you will work closely with the clinical evaluation and medical writing team, as well as consultants within K2Cs QA/RA team, Biological Safety, and more, providing strategic regulatory insight.

Each consultant typically manages 2-3 projects simultaneously with clients in the small to medium-sized MedTech and IVD segment. The assignments vary from short-term projects to longer assignments, offering a dynamic and interesting variety in your daily work.

About you

To thrive in this role, we believe you are a person with a strong background in clinical development within the medical device or IVD industry. You should be comfortable in being involved and contribute to clinical study designs and possess a strategic mindset. Your experience has likely given you the ability to guide and support clients effectively through the clinical development lifecycle.

You have a history of managing projects that meet regulatory standards and have an attention to detail. Your ability to communicate clearly in both Swedish and English will be essential as you document processes, respond to regulatory inquiries, and ensure that quality is never compromised.

You’re ready to take on a role where your day-to-day actions will have a direct impact on the quality and outcomes of our projects. You work well both independently and as part of a team, and you’re eager to share your knowledge with colleagues and clients alike.

Key Responsibilities

Key responsibilities as CPM:

Study Set-Up:

• Design and Planning: Contribute to the strategic planning and design of clinical studies, ensuring robust and compliant study protocols.
• Documentation Preparation: Lead the development of essential documents such as study plans, informed consent forms, and case report forms.
• Regulatory Submissions: Manage the submission of study protocols and materials to Competent Authorities, ensuring all regulatory hurdles are cleared for study initiation.
• Quality Assurance: Establish a quality framework for the upcoming study, ensuring all processes will meet or exceed regulatory standards.

Study Conduct:

• Operational Management: Oversee day-to-day clinical trial operations, ensuring the study is conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
• Site Management and Monitoring: Ensure efficient site management, including monitoring for compliance and data integrity.
• Consultant Training and Mentorship: Provide ongoing training and support to consultants, reinforcing best practices and a quality-centric culture throughout the study conduct phase.
• Budget and Resource Allocation: Monitor study budgets and resources, making adjustments as necessary to maintain efficiency and meet study goals.

Study Closure:

• Data Consolidation and Analysis: Oversee the locking of study databases, the analysis of data, and the drafting of study reports, ensuring accuracy and completeness.
• Final Regulatory Submissions: Manage the preparation and submission of final study reports and other closure documentation to Competent Authorities.
• Post-Study Review: Lead the review of study performance, identifying lessons learned and best practices for future studies.
• Team Debriefing: Conduct debriefing sessions with the study team to review outcomes, discuss successes, and areas for improvement to enhance future clinical operations.
• There is flexibility in the role depending on your interest and wish for continued professional learning.

Qualifications

Education Requirements/Certifications:

• Ph.D. or Master’s degree in relevant field or through work acquired relevant knowledge

Required Knowledge/Skill:

• Minimum of 2 years’ experience within the Clinical Development field
• Profound understanding of Good Clinical Practice for medical devices and in vitro diagnostic devices.
• Profound knowledge of clinical investigation requirements under MDR 2017/745 and IVDR 2017/746, and familiarity with related regulatory guidelines.
• Familiarity with the clinical and performance evaluation requirements as outlined in the MDR 2017/745 and IVDR 2017/746, along with associated guidelines.
• Full professional written and oral communication skills in English
• Proficient in spoken and written Swedish
• Thorough but pragmatic
• Solution oriented
• Positive
• Flexible

Information and contact details

Place of employment: Gothenburg, Lund or Stockholm

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

Are you interested in Key2Compliance but you don’t feel that this position is the perfect match?

Information

• Published: Tue, 26 Mar 2024
• Apply before: Tue, 30 Apr 2024

Contact information

• Jeanette Demorney
• jeanette.demorney@key2compliance.com

Key2Compliance We make complex things easier - all the way from idea to market - with focus on Life Science industry and complete solutions in all aspects of regulatory compliance.Key2Compliance is a full-service partner that offers complete solutions in all aspects of consultancy and training needs when it comes to Clinical Development, Biological Evaluations, Quality Assurance and Regulatory Affai #J-18808-Ljbffr

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