Ref #: 29809

Employment type: Permanent - Full-Time

Location: Home Based in Germany

Posted: 03-Aug-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!


Location: Germany home base, at least 2 days per month in Neuss office

The position is accountable for the operational oversight of assigned Investigator Initiated Studies (IISs) and collaborative studies and responsible for local management of IISs in one or more countries from start-up through close-out activities assuring that IIS study progress, safety reporting, drug and financial management adheres to the contract and all applicable Policies, SOPs, Work Instructions and regulatory requirements.


Key Responsibilities

• Services rendered will adhere to applicable SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• Complies with relevant training requirements.
• Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures 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 enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• 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 GTL MAO and CPL 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.
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study drug supply.
• Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
• With focus on quality, will work closely with GTL(Global Trial Leader) MAO, CPL(Clinical Program Leader) to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns.
• Ensures accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
• May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.
• If applicable, region specific deliverables will be specified.
• Advanced:
o Autonomy with execution of local trial management services.
o Depth of knowledge with local trial management services.
o Process leadership.


To Be Successful in The Role You Will Have

• BA/BS degree; degree in a health or science related field.
• Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Excellent decision-making and string financial management skills.
• Proficient in speaking and writing the country language and English. Good written and oral
communication skills as appropriate.


What is Offered

• Work for one of the global top two CROs, sponsor dedicated in one of the global top pharmaceutical companies fully integrated and from the sponsor’s perspective
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical sponsors
• Permanent contract
• Great work atmosphere
• Excellent career options
• Contribution to pension scheme

Sounds like a good fit? Get in touch with me today!
Send email to Ruth.Guibourg@docsglobal.com or call at +49 89 666 105 160



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.
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