Senior Contract Management Specialist

The Senior Contract Management Specialist is responsible for the timely and appropriate execution of  Confidentiality Disclosure Agreements (CDAs) Clinical Study Agreements (CSAs) associated Budgets and vendor agreements the legal sections of the Informed Consents and issues on other legal compliance regulatory and policy matters (such as Insurance Policies FMV FCPA etc.).

In partnership with Legal you ensure that issues and points of negotiation are settled rapidly in support of our new model to minimise or eliminate negotiation and our aspirational target of first pass acceptance of these documents. The overall aim is to keep CDAs Contracts and Budgets off the clinical study critical path for all AbbVie studies (both Site Management & Monitoring and CRO conducted studies). The responsibility is Global all countries except US and Japan.

KEY DUTIES AND RESPONSIBILITIES

• Serve as point person for their country/region for Legal Finance Site Management & Monitoring and Study Team.
• Accountable for timely Preparation and Execution of CDAs CSAs and Budgets and related vendor agreements either directly or via local staff where a region is supported and language requires local help. 
• Lead the direct negotiation of CDAs CSAs and Budgets with investigator sites with the help of the Monitor where local language necessitates. 
• Input into legal aspects of informed Consents to ensure first pass acceptance or rapid resolution of issues.
• Liaise with and seek Legal approval for deviations as required.
• Setting managing and communicating priorities to local affiliate stakeholders Legal and Finance in alignment with Study Plans and priority for start up.
• Provide input into ongoing update of the Playbooks and Templates with Legal.
• Tracking CDAs and CSAs in appropriate system and collecting relevant metrics.
• Collecting and tracking site intelligence and communicating such to appropriate stakeholders 
• Ensuring that CDAs and CSAs are off the critical path for study start up or study continued conduct where change orders are needed midstudy meeting timeline commitments.
• Report any adverse event within 24 hours as per AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties as requested

Qualifications :

• Tertiary qualification in health related area (Medical Scientific Nursing) preferred.
• Minimum three years clinical research experience including contract/budget negotiation.
• Proven negotiating skills tact and diplomacy.
• Understanding of medical and legal terminology and the application of business/financial concepts used in clinical research.
• Extensive knowledge related to ICH/GCP Guidelines and applicable local regulations. 
• Good planning and organizational skills and the ability to work effectively and efficiently in a dynamic
  environment with competing projects and deadlines.
• Ability to manage multiple priorities/projects.
• Good written and verbal communication skills with verbal fluency in English 
• Strong sense of urgency and ability to make decisions.
• Good communication and interpersonal skills. Positive team player. Good observational skills analytical and conceptual capabilities.
• High degree of flexibility when facing changes in the work environment.

Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information :

WAYS WE WORK

All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.

Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.

Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.

Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.

Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers. 

AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws. 

All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law. 

Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal. 

AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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