Study Contracts Manager

Study Start Up Manager - Hybrid Role Onsite

Are you ready to take on a pivotal role in the Site Activation Team as a Study Contracts Manager? Primarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level. Develops existing tools and processes to identify areas of improvement and ensures business continuity for oncology study delivery. Able to solve complex problems within a range of studies.

You will manage and provide leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication to set clear direction for the study teams and external Institutions.

Accountabilities:-Develop (in collaboration with the LSAD in charge of the study) and negotiate clinical site budgets based on Fair Market

Value. Leverage historical data, negotiation techniques, and address SoC with sites to support the delivery of oncology

trials, in the scope of study budget with optimizing cost savings.

· Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study

start-up and financial obligations.

· Be responsible for producing clinical site budget, in collaboration with LSAD, appropriate Payment Schedules based on

the Protocol and AZ policy and guidelines to provide to Clinical Delivery Team.

· Formulate and identify the proper agreement template to initiate negotiations.

· Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.

· Drive site start-up time by striving to execute CSA within KPI.

· For each agreement maintain the status of agreement, budgets, issues, and communications with both internal and

external sources.

· Attend and engage in scheduled project team meetings.

· Ensure final contract documents are consistent with agreements reached at negotiations.

· Contribute to set-up and execute Master confidentiality agreement and confidentiality agreement with key partner

sites, as appropriate locally

· Ensure all agreements are completed or captured in contracting system

· Support internal and external audits and litigation activities.

· Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated

documents. Ability to process agreement requests and identify correct legal entity and template to be used.

· Approve Clinical Study Agreements with final signature, according to Delegation of Authority.

· Negotiate a variety of common contractual issues related to standard template agreements

· Process amendments to contracts, as necessary, and manage that modification.

· Is member of LST, work with study teams to determine priorities for meeting timelines and SIV dates.

· Serve as a liaison between the legal and clinical trial teams.

· Negotiate master templates and rate cards with preferred or notable Institutions, including the creation,

implementation and following of specific partnering MSA with key oncology Institutions.

· As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business

exposure and policies/regulations.

· As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and

external customers.

· As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process

and budget development.

· Communicate confidently and competently to liaise with others through excellent communication and negotiation

skills.

· Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management

practices (schedule/cost forecasting and risk management).

· Demonstrate accurate knowledge of regulations and policies in order to maintain and develop the effectiveness of the

Clinical Study Agreement & Grant Management processes. · Demonstrate ability to follow and work within processes. · Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). · Additional Responsibilities May Include · · Ensure timely customization and completion of the CSA for designated studies. · Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents. · Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File. · Contribute to process improvements, knowledge transfer and best practice sharing

Essential Skills/Experience:

- Bachelor’s degree in relevant discipline

· Experience of Study Management within a

pharmaceutical or clinical background

· Knowledge of relevant legislation and new

developments in the area of Clinical Development and

Study Management

Desired Skills/Experience:

· Advanced degree within the field

· Professional certification

· Understanding of multiple aspects within Study Management

At AstraZeneca, we are driven by a bold vision to eliminate cancer as a cause of death. Our commitment to pioneering new frontiers in Oncology is fueled by cutting-edge science and technology. We empower our teams to make fearless decisions, take smart risks, and lead at every level. With a collaborative research environment that unites academia and industry, we are dedicated to improving the lives of millions affected by cancer. Join us on this exciting journey where courage, curiosity, and collaboration are at the heart of everything we do.

Ready to make an impact? Apply now to join our team!

The annual base pay for this position ranges from $105,735.20 - 158,602.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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.