Clinical Research Budgets and Contracts Specialist

Company Description

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for a Budget and Contracts Specialist at Wake Research, an M3 company. This position is remote.  

Job Description

The Budget and Contracts Specialist will be responsible for supporting a portfolio of work within the organization, including: 

1. negotiating clinical trial agreements for studies awarded to M3 Wake’s Clinical Research sites
2. negotiating Confidentiality Agreements (CDAs), master CDAs or Non-Disclosure Agreements (NDAs)
3. negotiating vendor services agreements (VSA) or Master Service Agreements (MSAs) with M3 Wake Research approved vendors

The person in this role will work directly with the Vice President of Clinical Operations to understand and follow through on all contractual aspects of clinical research. This includes collaborating to prepare and review contracts, and implementing the approval, filing, and compliance processes. The Budget & Contracts Specialist is also responsible for the appropriate compensation procedures for select contracts.

Essential Duties and Responsibilities:

• Assist with the creation, administration and overall management of M3 Wake Research site contracts and budget activities
• Negotiation and execution of site budget
• Negotiation and execution of site contract
• Management of budget and contract amendments driven by study protocol amendment and protocol addenda
• Compile and maintain a library of procedural costs to for budget development
• Compile and maintain library of contract terms from key customer accounts to facilitate more efficient contract negotiations
• Accurate and timely tracking and reporting of contract and proposal data network wide
• Submission of final deliverables in accurate and timely manner
• Assist with the management of the negotiation process, proactively escalating issues or proposing solutions in order to expedite the process
• Use commercial, fiscal and budgetary skills to develop budgets that match the service offering while ensuring costs are accurate and justifiable including all variables required
• Create payment terms to ensure cash neutrality and conform with company standards
• Liaise, directly or indirectly with Sponsors and CROs representing the sites as it relates to contracts and budgets
• Work closely with Business Development and study start-up team to ensure timely completion of start-up activities relating to budgets and contracts
• Work closely with site clinical staff to collect study details to facilitate budget development
• Work closely with internal finance team to assist as a resource for interpreting contractual language and budgets for billing and revenue recognition
• Work closely with in house legal department to ensure proper and necessary language of contracts
• Understand and comply with procurements, legal and financial requirements and procedures

Qualifications

• Bachelor's degree in a business field or life science degree with equivalent work experience
• Experience in a CRO, pharma/biotech, site network outsourcing, or equivalent paralegal/legal contract experience for at least 2 years
• Excellent analytical skills including use of advanced MS Excel software, oral and written communications, strong attention to detail, prioritization and time management proficiencies
• Ability to work effectively with minimal supervision
• Ability to multi-task constantly
• Comfortable with financial calculations
• Ability to read and understand legal documents highly preferred
• Ability to understand finance budget documents highly preferred

Additional Information

About M3: 

M3 USA is at the forefront of healthcare innovati