Study Start Up Manager (m-f-d), Germany, Rare Diseases

We have an opportunity to join our team as a Study Start Up Site Activation Manager, the role is client dedicated to a rare disease biotech and the position is focused on Ethical Committee (EC) submissions in Germany, you may also be required to work on EC submissions for Austria and Switzerland. We are open to a broad background of candidates from 2 to 10+ years of Study Start-Up (SSU) experience, important is to have prior experience in submitting Ethical Committee submissions. Applicants with more junior levels of SSU experience will be considered at different job title levels, from Study Start Up Lead (m-f) to Study Start Up Manager (m-f). 

About ICON:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

• Manages start-up activities for assigned studies at the regional level including supporting site identification/site recruitment/site selection, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs) readiness, and overall regional site activation readiness to ensure deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations.
• Ensures that clinical delivery project team members and any other cross-functional team members needed to support regional site activations understand responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance, providing feedback to individual and functional manager (FM) as appropriate.
• Communicates effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Selects appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.
• Ensures quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines and local regulations for IP release and site activations.
• Identifies and escalates potential risks with the regional start-up activities and deliverables, inclusive of proactive mitigation planning.
• Conducts analysis of regional start-up risks and issues, acting and documenting in the appropriate system. Escalates as appropriate through functional management and study start up manager.
• Analyzes metrics and reports of regional performance against key performance indicators
• Escalates out-of-scope task requests for review and approval prior to execution.
• Creates, maintains and collaborates on applicable project documents, plans, templates and tools.

• Bachelor’s degree in a business-related, health, life sciences or other relevant field of study
• At least 2 years of experience in Study Start-Up activities.
• Prior experience in Ethical Committee (EC) submissions in Germany, experience in Austria or Switzerland is preferred. 
• Fluent German and fluent English. 

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Please apply for the position directly or contact Michael Kellitt, the lead Recruiter for this position for more information:

Michael.Kellitt@docsglobal.com