Contract Manager - Contract - Onsite
Proclinical is seeking a Contracts Manager to join a top recruiting firm. This is a contract role and is located in Wilmington, DE.
Skills & Requirements:
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
- Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry.
- Strong interpersonal, negotiation, communication and time management skills.
- Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.
- Five years' experience in pharmaceutical or health care industry, or seven to ten years of experience as a paralegal or contractor administrator in pharmaceutical industry.
- 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 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
- 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.
- Must be eligible to work in the US.
The Contract Manager will:
- 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 our 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.
- Ensure all agreements are completed or captured in contracting system 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.
- 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 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 our 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 our 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.
- Development of study level budget based on Protocol using FMV tool
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.