Ref #: 30094

Employment type: Permanent - Full-Time

Location: Germany

Posted: 08-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!


Home base Site Contract Manager (m/f/d) Needed!
(Country OR Cross Country)

Prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.


Key Responsibilities

• Services rendered will adhere to applicable company SOPs, WIs, policies, local regulatory
• requirements, etc.
• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and company pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Work with the global CCS (Contract & Compliance Service) team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC),
• Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as
appropriate.
• Track all aspects of legal document and metrics. Determine potential needs for contract
amendments and manage amendment lifecycle.
• Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS,GCDO and operating companies. Comply with requests from QA and auditors.
• Full utilization by timely and accurate time reporting (BEACON).
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. SATS) according to expectations (metrics) and archiving retention requirements.



To Be Successful in The Role You Will Have

• 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor Familiarity with clinical research processes.
• Ability to work effectively in cross function teams.
• Able to work independently as well as in a collaborative team environment.
• Strong and proven negotiation and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Fluency in English and German is a must
• Must demonstrate innovative spirit, have strong interpersonal skills, ability to manage a high volume of work.


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.

#sitecontractmanagerjob