Lead global rare‑disease trials that shape the future of patient care through expert clinical study management and cross‑functional leadership.
Proclinical is seeking a Clinical Study Manager for a contract role based in Sweden. In this position, you will lead and manage cross-functional clinical study teams, ensuring the successful delivery of clinical study activities within agreed timelines, budgets, and quality standards. This role focuses on rare disease studies and requires strong leadership, organizational, and problem-solving skills.
Responsibilities:
- Build relationships with investigators, study site personnel, external service providers (ESPs), and other stakeholders to ensure operational feasibility and understanding of patient needs.
- Lead and manage cross-functional clinical study teams, ensuring objectives and responsibilities are met.
- Oversee all clinical study activities, ensuring adherence to timelines, budgets, and quality standards.
- Ensure a quality database lock and completion of the Clinical Study Report.
- Identify and document risks related to clinical study activities and deliverables.
- Set up and maintain clinical tracking tools and study contact lists throughout the study lifecycle.
- Forecast and manage study budgets and contracts.
- Coordinate activities related to Investigational Medicinal Products, including ordering, labeling, distribution, and expiry date extensions.
- Ensure delivery and proper archiving of key clinical study documents.
- Define the scope of work for ESPs and oversee their performance, ensuring compliance with applicable guidelines and regulations.
- Monitor study progress and ensure all activities align with ICH-GCP guidelines, GPP guidelines, and regulatory requirements.
- Contribute to process improvements to enhance resource utilization and study quality.
Key Skills and Requirements:
- University degree in Life or Health Sciences.
- Extensive knowledge of the clinical study process, including planning, conducting, and reporting multicenter international studies.
- Proven ability to lead multidisciplinary teams, with strong team-building, negotiation, and conflict resolution skills.
- Experience managing global clinical outsourcing and working with external service providers.
- High level of proactivity, commitment, and energy.
- Strong leadership, coaching, and interpersonal skills.
- Excellent problem-solving abilities and a customer-oriented mindset.
- Strong organizational and multitasking skills.
- Proficient in written and oral communication in English.
If you are having difficulty in applying or if you have any questions, please contact Erin Magalie at e.magalie@proclinical.com.
Apply Now:
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