Site Engagement Liaison Manager (m-f-d), Germany, Pharmaceuticals

The Site Engagement Liaison Manager (m-f-d), also known as a Clinical Site Lead will develop relationships with clinical trial investigators and research site staff to ensure the medical success of the clinical research sites across the DACH region. This position has direct communication with our pharmaceutical client's Head Quarters who are located in Germany and will communicate on both a scientific level for medical affairs, on a regulatory level, a senior manager clinical operations level to convince internal stakeholders on the needs and status of the clinical trials. In this position you are not just not just boosting patient recruitment, however you are also responsible for raising protocol related issues, liaise with investigators and GCP quality auditing CRO (including CRA spot checks).  If you are currently a Clinical Project Manager and would like to work in a medically driven role, that requires hands-on travel to sites across the DACH (Germany, Austria and Switzerland) region then you may be a great match for this role, we are also considering candidates with a Clinical Research Associate Lead background. 

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.

 Establish and manage site relationships, including but not limited to:
 Act as liaison between the company and investigational sites, building investigator and site staff awareness on compounds
 Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
 Independently perform activities associated with the evaluation of investigational sites to build company network
 Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
 Develop knowledge of site capabilities and past performance to assess their potential as participating sites 
Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:
 Support Site Agreement negotiations, including stand-alone and Master Site Agreements
 Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those
 Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines
 Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions
 Ensure ICH/GCP/local regulatory requirements are observed

In addition, employee may be assigned one or more ‘added value’ roles:

Therapeutic Area Expert Assignment
 SME with focus to increase disease knowledge within the team by sharing materials (training/articles/abstracts) and/or arranging training sessions

Country Start-up Specialist Assignment
 Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and
company agreed cycle times
 Work closely with respective Clinical Site Leads to support them in issue resolution for site activation
 Collaborate with external vendors to identify process(es) requiring improvement at the Country level,
build action plans to strengthen/improve those and track impact of actions
 Support OSM model by acting as a local SME

Clinical Trial Delivery Lead Assignment
 Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those
 Advise the Trial Team on trends/issues and facilitate solutions, working closely with the CTL to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and
external stakeholders as appropriate, including ICSO/CTE Leadership
 Develop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site Leads
 Participate in Investigator/Study Coordinator Meetings and promote information sharing with the Clinical Site Leads as needed.

• 8+ years experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct. With less than 8+ years clinical operations experience we can consider candidates when appropriate level of autonomy and confidence to lead both operational and science-driven site engagement interactions with Investigators and Site Staff, as well as having strong collaboration, influencing and communication skills to partner effectively with our CROs. Experience of overseeing or mentoring other CRAs so they already have that ‘oversight’ perspective crucial to the CSL role / Lead CRA experience
• Bachelor’s degree, or local equivalent, in a life-science, scientific discipline / medical. 
• Fluent German and English.

•  

  High Travel, domestic and international.

• Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
• Oncology and/or Neurology and/or Immunology TA experience desired
• Highly developed organizational, problem solving and analytical skill, with the ability to prioritize
• Time-sensitive tasks and work independently, and to make decision and to progress projects.
• Must have competent computer skills.

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.

Would you like to know more? Please contact the lead recruiter, michael.kellitt@iconplc.com

Michael Kellitt

Senior Recruitment Consultant DACH at ICON plc

+49 173 170 2681

michael.kellitt@iconplc.com