Clinical Program Manager Cepheid Solna
Dfind Science & Engineering AB / Apotekarjobb / Stockholm
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Cepheid is one of the fastest growing companies in molecular diagnostics. The company's unique diagnostic platform is used throughout the world, making a difference for patients as diagnosis and choice of treatment is facilitated by the test results. Cepheid offers a broad range of diagnostic products in virology, bacteriology and oncology that can meet tomorrow's demands for safe, fast and flexible diagnostic both in Western countries and in countries with limited resources. Globally, the company is represented by its headquarters in Sunnyvale, California, sales and marketing offices in Toulouse, France and technology and chemistry center in Bothell, Washington. Cepheid AB, part of the global Cepheid group, is located in Solna, Sweden and has around two hundred employees, mainly in production, quality control, research and development.
As a Clinical Program Manager at Cepheid your primary function is to represent Clinical Affairs on cross-functional teams and ensure direct report(s) have the appropriate skills, training and professionalism to conduct multi-center global clinical trials on behalf of Cepheid and work with them to achieve company and professional goals. The Clinical Program Manager is responsible for managing global clinical trials and programs associated with Cepheid's infectious disease programs to support US and ex-US registrations. The Clinical Program Manager reports to the Sr. Director of Clinical Affairs.
The role is positioned in Solna but will work on a global platform and will, to begin with, have one direct-report who is based in UK.
Responsibilities:
Management of Associates:
• Leads and inspires Clinical Research Associate(s) through clear communication and setting example
• Sets clear objectives and works with Associates to develop solid development goals and meaningful plans for achievement in alignment with company goals; conducts performance appraisals
• Develops and implements training plans to ensure compliance with Cepheid Quality Systems, regulatory requirements, study protocols, department SOPs and other as required
Study Conduct:
• Represents the Clinical Affair function on core teams and acts as a cross functional liaison to ensure study plan aligns with business development strategies
• Manages the execution and operational plan of global clinical trials projects and programs including timeline and deliverables as well as developing and managing the approved budget throughout the lifetime of the trials
• Responsible for ensuring that clinical protocols are developed, reviewed and approved in accordance with the master schedule
• Ensures investigational site qualification and monitoring (initiation, interim and closeout) are conducted according to predeveloped plans and Cepheid SOPs
• Responsible for the development of study-specific documents (e.g. clinical monitoring plans, case report form content, informed consents, etc.)
• Manages the clinical budget and develops contingency plans for clinical trials
• Monitors adherence to clinical protocols.
Qualifications:
• We think that you have a Master's Degree or equivalent combination of education and experience to perform at this level and are certified in project management. In addition you have:
• Several years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical
• Project lead or project management experience .
• Knowledge and understanding of FDA and IVDR requirements, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
Preferred Qualifications:
• A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology Biochemistry and/or Human Physiology is preferred
• IVD experience is highly desired
• Experience working with infectious diseases is strongly preferred
To be successful as a Program Manager at Cepheid you need to be results-oriented and have experience in working in an international and technical environment. You are both organized and collaborative and have excellent communication skills. You have strong oral and written communication skills and strong technical writing skills. You work independently, have strong leadership and high level of interpersonal skills. Cephied offer an independent role that span over many functions over If you share our core values: Integrity, Quality, Customers, Employees, Collaboration, Drive to Succeed, you will enjoy working with us.
Company: Cepheid
City: Solna
Employment: full time, the role includes approximately 30% travels.
Last date of application: 2018-03-11
For information: In this recruitment Cepheid is collaborating with Dfind Science & Engineering. For questions please contact responsible recruitment consultant Peter Janson 072-5883223. Apply via
www.dfind.se/science-engineering [
http://www.dfind.se/science-engineering no later than 2018-02-17 ] We need you application in English.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-02-19ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-03-13
Ange följande referens när du ansöker: 201122070
Klicka på denna länk för att göra din ansökanKontaktPeter Janson
peter.janson@dfind.se 072-5883223
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3974266
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