SENIOR STUDY CONTRACT MANAGER

The Senior Study Contract Manager Sponsor dedicated, play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.
  SrSCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.
  What you will be doing Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
Develop and negotiate clinical site budgets based on Fair Market Value.
Negotiate agreement language and budget with clinical study sites.
Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
Ensure final contract documents are consistent with agreements reached at negotiations.
Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
Support internal and external audits activities.
Ensure compliance with Sponsor’s Code of Conduct and company policies and procedures relating to people, finance, technology and security.
Ensure that all contracts are included in the TMF               Upon local decision, additional responsibilities may include*.
Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences.
Support preparation and negotiation of a Local Master Service Agreement Contribute to process improvements, knowledge transfer and best practice sharing.
*Note.
Additional responsibilities may be adjusted locally You Are Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local regulations.
Basic understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Excellent attention to details.
Good written and verbal communication skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
Ability to travel nationally/internationally as required.
Ability to work in an environment of remote collaborators.
Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry Manages change with a positive approach for self, team and the business.
Sees change as an opportunity to improve performance and add value to the business.
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
Good analytical and problem-solving skills.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Familiar with risk-based monitoring approach including remote monitoring.
Good cultural awareness.
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
  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.