What are the responsibilities and job description for the Sr / Manager, Clinical Business Operations position at System One Holdings, LLC?
Manager, Clinical Business Operations
Job Category : Clinical Development
Full-Time : PERM
Locations : Florham Park, NJ (hybrid - 50% of the month in the office)
Leading Pharmaceutical Company located in NJ is hiring a Manager of Clinical Business Operations with 5 years industry experience. If you want to be a part of this groundbreaking work, please apply!
Job Details :
The Manager of Clinical Business Operations will be responsible for clinical outsourcing and relationship management activities, including :
Vendor selection (conducting Request for Proposal (RFPs) proposal review and analysis and budget negotiations, development, and execution).
Contract management throughout the life cycle of study, setting of standards, cost savings development / tracking and budget management in support of the clinical development programs.
Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality agreements as needed, Master Services Agreements, Work Orders, Amendments, Change Orders, Lab Agreements, and any other type of agreements needed for clinical studies).
Actively managing other clinical financial obligations.
CRO / vendor management, vendor selection & oversight, sourcing process for clinical operations.
RESPONSIBILITIES
Research, review, and / or assess potential CROs and vendors in collaboration with the Director and other colleagues based on needs.
Work with Clinical Development on planning and management of clinical study-related outsourcing activities with enough communication.
Work with other functions globally (Biometrics team (Data Management, Programming, and Statistics), Regulatory, Drug Safety, and other functions) on supporting all applicable outsourcing activities.
Facilitate the creation and execution of all contract documents, manage the review and negotiation of contract terms, and partner in collaboration with Legal, Finance, and other internal stakeholders as needed to finalize.
Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners, including strategic partnerships and preferred provider relationships.
Ensure clinical programs are executed within the projected budget, and promptly communicate any change in the scope of budget.
Collaborate with Finance on managing the latest estimate (LE) and annual / long-range planning activities for Clinical.
Manage all activities in accordance with company SOPs, FDA, & ICH guidelines, and regulations.
Collaborate closely with headquarters in Japan as well as European office colleagues as required.
MINIMUM JOB REQUIREMENTS
Bachelor's Degree or equivalent education required, preferably in Life Sciences, Finance, or Business. An MBA is a plus.
A minimum of 3 years' experience, including outsourcing for clinical trials, vendor negotiations, operations management, accounting, and finance.
Pharmaceutical industry experience strongly preferred dealing with Research and Development functions. Experience dealing with a Clinical Development department and Global clinical trial experience.
Excellent written and oral communication skills with the ability to generate concise reports and verbal updates.
Demonstrated strong analytical skills.
Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint) and Adobe. Experience working in Excel - including pivot tables, database & lookup formulas is a plus.
Must be flexible and adaptable to changing project priorities, work assignments, and deadlines.
Must live a commutable distance from our Florham Park Corporate offices.
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