Study Contract Manager

Study Contract Manager – Hybrid Role Onsite Are you ready to take on a pivotal role in the Site Activation Team as a Study Contract 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. 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. Accountabilities Develop and negotiate clinical site budgets based on Fair Market Value, leveraging historical data and negotiation techniques. Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations. Produce clinical site budgets and appropriate payment schedules based on the protocol and AZ policy and guidelines. Formulate and identify the proper agreement template to initiate negotiations. Act as point of contact and interface with Legal when necessary to ensure integrity of contracts. Drive site start‑up time by executing CSAs within KPI. Maintain the status of agreements, budgets, issues, and communications with internal and external sources. Attend and engage in scheduled project team meetings. Ensure final contract documents are consistent with agreements reached at negotiations. Set up and execute Master confidentiality agreements and confidentiality agreements with key partner sites, where appropriate locally. Ensure all agreements are completed or captured in the contracting system. Support internal and external audits and litigation activities. Negotiate appropriate terms and conditions of informed consent forms and other clinical agreements, identifying correct legal entities and templates. Approve clinical study agreements with final signature according to delegation of authority. Negotiate common contractual issues related to standard template agreements. Process amendments to contracts and manage modifications. Serve as a member of LST, working with study teams to determine priorities for meeting timelines and SIV dates. Serve as liaison between the legal and clinical trial teams. Negotiate master templates and rate cards with preferred or notable institutions, including creation, implementation and follow‑up of specific partnering MSAs with key oncology institutions. As a subject matter expert, exhibit contract and negotiation expertise to balance external business exposure with policies and regulations. Demonstrate understanding of how contractual terms add value to internal and external customers. Possess detailed and in‑depth knowledge of contract precepts, the contracting process and budget development. Communicate confidently and competently to liaise with others using excellent communication and negotiation skills. Demonstrate understanding of how contracting and budgeting processes support project management practices such as schedule, cost forecasting and risk management. Demonstrate accurate knowledge of regulations and policies to maintain and develop the effectiveness of the clinical study agreement and grant management processes. Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE. Additional responsibilities: Ensure timely customization and completion of the CSA for designated studies. Participate in training and mentoring new members of the local study delivery team to ensure 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 a relevant discipline. Experience in 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. Benefits and Compensation Annual base pay ranges from $112,154.40 to $168,231.60. Base pay offered may vary depending on market location, job‑related knowledge, skills, and experience. Additional benefits include a qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves, and health benefits including medical, prescription drug, dental, and vision coverage. Employees may also receive a short‑term incentive bonus opportunity, equity‑based long‑term incentive participation (for salaried roles), retirement contributions (for hourly roles), and commission payment eligibility (sales roles). All positions are at‑will, and the company reserves the right to modify base pay at any time. Equal Employment Opportunity Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. We welcome and consider applications from all qualified candidates, regardless of protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr Dormont Manufacturing Co