Ref #: 28648

Employment type: Permanent - Full-Time

Location: Germany, home based

Posted: 02-Jul-2021

Description

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.


The Role:

DOCS is working in partnership with a highly prestigious organization with one of the most robust clinical study pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry. We are looking for interested Global Clinical Trial Managers who want to become a part of this family and add to the success story.

The Global Clinical Trial Manager provides global, regional or complex local management of
clinical trial data generating activities in a country or countries. Responsibilities include operational oversight of assigned project(s) for end to end project management including start-up, execution, close-out, analysis and reporting.


Key Responsibilities:

- Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.
- Responsible for overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrolment will be met across the allocated countries.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Escalates corrective and preventive actions (CAPA) to when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target and works with GCO/CRO staff in the set up and coordination of Investigator meetings, if applicable.
- Delivers competent vendor management to support the study and may submit requests for vendor services and support vendor selection.
- Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
- May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.


To be successful in the role, you will have:

• Bachelor’s degree or equivalent required, preferably in Life Sciences.
• Strong clinical trials background of 8 or more years of clinical study management experience in the pharmaceutical industry or CRO.
• Hands on CRO management, budget management and cross functional management experience.
• Excellent communication skills.
• Excellent decision-making and strong financial management skills.
• Flexibility and ability to manage study teams in a virtual environment.


What is offered:

• Work within one of the most successful global pharmaceutical companies of today
• 100% Home Based
• Permanent contract
• Great work atmosphere
• Interesting pharmaceutical products and indications
• Contribution to pension scheme


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.

To apply:
Would you like to know more? Please submit your CV to timo.kindermann@docsglobal.com or via our homepage www.ICONplc.com/FSP. We are looking forward to getting to know you.
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