Study Contract Manager

The Study Contract Manager (SCM) 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. SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders. SCM might have different internal titles based on the experience level (SCM, Senior SCM).

The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).

Typical Accountabilities

• 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 audit activities.

• Ensure compliance with AstraZeneca’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.

Essential

• Bachelor's 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

Desirable

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 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.

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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The annual base pay for this position ranges from $147,017.60 - $220,526.40. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.