Clinical Contracts Specialist Jobs

Position Details:

Job Title:Pricing and Contract Strategy Manager (Clinical Contracts)

Assignment Duration: 12+ Months with possible extension

Location:Wilmington, DE (Remote)

Notes:

Team handles clinical contracts with the sites.

o Looking for someone that has experience that has negotiating contact language and budgets with clinical contracts.

o Part of the activation of a clinical trial.

o Contract is what is put into place to activate a study at a location.

o There is no requirement for a legal background but it is helpful, as long as they have the experience.

o Day to day managing own assigned workloads, following up with sites that they have not hears from in a couple of weeks, review the sites and counter if needed.

o Keeping study teams up to date

o Day will be spent negotiating and following up. Lots of communication and negotiation

o Minimum of 5 years’ experience.

o Open to 100 percent remote candidate, core hours are 9-3 EST.

o Manager would like to see candidates with Clinical Research experience.

TOP 3 THINGS HM WOULD LIKE TO SEE ON RESUMES:

1. Budget Negotiation

2. Language negotiations

3. Process-Understanding of how to proceed through the negotiations

Job Summary:

·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.

Typical 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 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 Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

·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 Requirements:

·Bachelor’s degree in relevant discipline

·5 years’ 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