Current jobs related to Study Contract Manager - Wilmington - AstraZeneca

  • Specialist Study Management

    3 months ago

    Wilmington, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionWilmington, DEContract Duration: 12-36 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area. Candidates must be local to Wilmington, DE, non-remote position Own and maintain quality for the study file as the local study team TMF ownerResponsible for...

  • Specialist Study Management

    2 months ago

    Wilmington, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionWilmington, DEContract Duration: 12-36 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area. Candidates must be local to Wilmington, DE, non-remote position Own and maintain quality for the study file as the local study team TMF ownerResponsible for...

  • Director of Managed Care Contracting

    3 months ago

    Wilmington, North Carolina, United States Johns Hopkins Medicine Full time

    Job SummaryReports to the AVP, Network Management and is responsible for the overall direction and management of the contracting value-based care (VBC) and network development strategies. Responsibilities include negotiating provider reimbursement rates and contract terms, developing value-based care arrangements, planning, directing, organizing and...

  • Analyst - Contract Management & Payor Variance

    1 month ago

    Wilmington, United States ChristianaCare Full time

    Do you want to work at one of the Top 100 Hospitals in the nation? We are guided by our values of Love and Excellence and are passionate about delivering exceptional health care. Come join us at ChristianaCare!ChristianaCare is one of the country's most dynamic healthcare organizations, centered on improving health outcomes, making high-quality care more...

  • Contracts Advisor

    3 weeks ago

    Wilmington, North Carolina, United States Oceaneering International Full time

    Company Profile Oceaneering Technologies (OTECH) develops, manufactures, and operates customized marine systems, shipboard equipment, subsea vehicles, and engineered solutions for commercial and U.S. military vessels.Oceaneering Aerospace and Defense Technologies (AdTech) delivers solutions that enable humans to work safely and effectively in harsh...

  • Social Studies Teacher

    3 weeks ago

    Wilmington, United States Focused Staffing Full time

    Job DescriptionJob DescriptionPosition: Social Studies Teacher (Middle School, Grades 5 to 8)Compensation Rate: Pays up to $50 per hourReports to: PrincipalPrimary Teaching Responsibilities: Follow and support all the school's policies, procedures and expectations in professional and educational matters that are set by the Principal and President. The...

  • Social Studies Teacher

    3 weeks ago

    Wilmington, United States Focused Staffing Full time

    Job DescriptionJob DescriptionPosition: Social Studies Teacher (Middle School, Grades 5 to 8)Compensation Rate: Pays up to $50 per hourReports to: PrincipalPrimary Teaching Responsibilities: Follow and support all the school's policies, procedures and expectations in professional and educational matters that are set by the Principal and President. The...

  • Contracting Specialist

    1 month ago

    Wilmington, North Carolina, United States Johns Hopkins Medicine Full time

    Johns Hopkins Health Plans is a leader in provider-sponsored health plans. If you are interested in improving how healthcare is delivered, and have a passion to be at the forefront of change, JHHP is the place to call home. YOU belong here. What awaits you: Work-life balance - This is a hybrid role requiring you to come in only 1 day per weekMedical,...

  • Contract Specialist

    1 month ago

    Wilmington, United States Sargent & Lundy Full time

    Description Sargent & Lundy is a global leader in power and energy consulting, where innovation meets integrity, diversity, and a commitment to quality. Our distinctive capabilities provide domestic and international clients and partners with a thoroughly reliable source of comprehensive expertise. Sargent & Lundy offers challenge, flexibility,...

  • Contract Specialist/Administrator

    3 months ago

    Wilmington, United States LAUNCH Technical Workforce Solutions Full time

    Overview: Contract Specialist/Administrator LAUNCH Technical Workforce Solutions is seeking a Contract Specialist/Administrator for an opportunity in Wilmington, Ohio. The Contracts Specialist reviews contractual agreements with an understanding of the contracting parties requirements based on negotiations; assists with drafting of legal documents as...

  • Waste Management Engineering Lead

    11 hours ago

    Wilmington, North Carolina, United States Arcadis Full time

    About the Role:Arcadis is seeking a highly experienced Principal Solid Waste Management Consultant to join our Resilience Team in the Mid-Atlantic region. As a key member of our team, you will be responsible for leading and managing the delivery of solid waste related engineering and business advisory services to municipal clients in the DC Metro area and...

  • Management Analyst III

    1 month ago

    Wilmington, United States DelDOT Full time

    Summary Statement This position is a part of the FOCUS Team and will serve asa Product Owner. Product Owners areresponsible for actively managing the Product Backlog and overseeing each stageof the development process, including requirements analysis, planning, design,development and testing as Divisions continue to refine and enhance the...

  • Principal Medical Writer

    23 hours ago

    Wilmington, United States Proclinical Staffing Full time

    Principal Medical Writer - Contract - Wilmington DEProclinical is seeking an innovative Principal Medical Writer to lead a dedicated team. Primary Responsibilities:This role will be responsible for developing clinical documents for global regulatory submissions. The successful candidate will work closely with multidisciplinary project teams to create...

  • Senior Management Analyst

    1 week ago

    Wilmington, Delaware, United States DelDOT Full time

    OverviewJoin DelDOT and Shape the FutureThe Delaware Department of Transportation (DelDOT) plays a vital role in the state’s infrastructure and community development. Our mission encompasses a wide range of responsibilities, including transportation planning, project management, and enhancing the quality of life for all Delawareans.DelDOT is committed to...

  • Associate Director Country Operations Management

    3 weeks ago

    Wilmington, United States AstraZeneca Full time

    This is what you will do:The Associate Director Country Operations Management (AD COM) is responsible for day-to-day management of a dedicated functional group(s) within Country Operations, and is responsible for planning and utilization of staff resources, objective setting and performance development. The AD COM is responsible for their direct reports...

  • Principal Solid Waste Management Consultant

    11 hours ago

    Wilmington, North Carolina, United States Arcadis Full time

    About the Role:Arcadis is seeking a highly skilled and experienced Principal Solid Waste Management Consultant to join our Resilience Team in the Mid-Atlantic region. As a key member of our team, you will be responsible for leading and managing the delivery of solid waste related engineering and business advisory services to municipal clients in the DC Metro...

  • Management Analyst III

    1 month ago

    Wilmington, United States DelDOT Full time

    Introduction Start your Career at DOS! The Department of State's (DOS) responsibilities are found in virtually every aspect of state government: economic development, finance, transportation, housing, education, culture and quality-of-life issues. Our mission at DOS range from preserving Delaware’s historical sites and collections, to supporting...

  • Global Sourcing Program Manager

    1 month ago

    Wilmington, United States Solenis LLC US Full time

    Solenis is a leading global producer of specialty chemicals focused on delivering sustainable solutions for water-intensive industries, including consumer, industrial, institutional, food and beverage, and pool and spa water markets. Owned by Platinum Equity, the company’s product portfolio includes a broad array of water treatment chemistries, process...

  • Senior Project Manager

    2 weeks ago

    Wilmington, United States BE&K Building Group Full time

    The Senior Project Manager is responsible for all project administration including all contractual requirements, agreements with trade partners, purchase orders, and risk management. This individual also manages general work performance and quality, and overall team progress against the project plan.ResponsibilitiesLead and communicate with BE&K Field...

  • Senior Project Manager

    2 weeks ago

    Wilmington, United States BE&K Building Group Full time

    The Senior Project Manager is responsible for all project administration including all contractual requirements, agreements with trade partners, purchase orders, and risk management. This individual also manages general work performance and quality, and overall team progress against the project plan.ResponsibilitiesLead and communicate with BE&K Field...

Study Contract Manager

1 month ago

Wilmington, United States AstraZeneca Full time
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you are our kind of person.

A position providing 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.

Major responsibilities

• Develop and negotiate clinical site budgets based on Fair Market Value. Leverage historical data, negotiation techniques, and address SoC with sites to realize 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 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.

• Function 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.

• 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 the 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.

• 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 with preferred or notable 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 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

• 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.

Requirements for the Role

• Bachelor's degree in related discipline, preferably in life science and 3 years of experience. In lieu of degree 5 years of relevant experience and High School Diploma or GED with a Certificate in Contract Management/ Paralegal.

• Strong interpersonal, negotiation, communication, and time management skills.

• Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.

• Strong oral, written, and organizational skills.

• Fluent knowledge of spoken and written English.

• Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Good medical knowledge in relevant AZ Therapeutic Areas.

• Basic understanding of the drug development process.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data

management.

• Ability to adapt to change

• Ability to travel nationally as required.

• Maintain ability to deliver quality according to the requested standards.

• Demonstrate ability to work in an environment of remote collaborators.

• Manage 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.

• Exhibit ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

• Demonstrate excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.

• Possess good analytical and problem-solving skills.

• Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.

• Possess good cultural awareness.

• Prove 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.

• Maintain team oriented and flexible approach; possess ability to respond quickly to shifting demands and opportunities.

• Exhibit customer focus in collaboration with sites and external stakeholders.

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.