Clinical Research Budgets and Contracts Specialist

Company Description

M3 is the global leader in digital solutions in healthcare. We work with a range of sectors including healthcare, life sciences, pharmaceuticals, biotechnology and charities; services provided to these sectors include market research, medical education programs, promotional programs, clinical development, job recruitment and clinic appointment services. M3 has grown by more than 20% year-on-year for the past 15 years, achieving over 1 billion dollars in revenue annually.

Founded in 2000, with start-up investment capital from Sony, M3’s mission is to make use of the internet to increase, as much as possible, the number of people who can live longer and healthier lives, and to reduce, as much as possible, the amount of unnecessary medical costs. Key achievements of M3 Inc. include:

• Named in Fortune’s 2020 ‘Future 50’ list, ahead of Facebook and Amazon
• Ranked in Forbes’ 2020 Global 2000 list of the world’s largest public companies
• M3 is the only company incorporated after the year 2000 to be included in the Nikkei 225 Index
• Listed in Forbes’ ‘Asia’s 200 Best Over a Billion’ in 2019
• In 2020 M3 founded the ‘M3: Stop COVID-19 Fund’ and pledged one billion yen to support COVID-19 related initiatives

M3’s legacy lies in the power of trusted physician platforms. Around the world, M3 organizations leverage these highly engaged digital communities to deliver medical education, job placement, and market research, to improve global patient outcomes.

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

About the Business Division:

M3 Wake Research 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). M3 Wake Research, Inc. is one of the largest independent Clinical Research multi-site companies in US, with close to 30 owned and managed research sites across the country that is continuing 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 USA. 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.

Job Description

Mission of the Role: 

The Budget and Contracts Specialist will be responsible for supporting a portfolio of work within the organization.  This portfolio of work will include:

1. negotiating clinical trial agreements for studies awarded to Wake 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 a Vice President of Business Development 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 Associate is also responsible for the appropriate compensation procedures for select contracts.

Essential Duties and Responsibilities:

Including, but not limited to the following:

• Assist with the creation, administration and overall management of M3 Wake research site contracts and budget activities
• Preparation of contracts and contract amendments including budget development
• Compile and maintain a library of procedural costs to for budget development and feasibility
• 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 site as it relates to contracts and budgets and making necessary revisions
• 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

Qualifications

Requirements

Experience: 

• 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

Knowledge, Skills, Abilities: 

• 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 would be advantageous
• Ability to understand finance budget documents would be advantageous
   

Additional Information

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description at any time. 

M3 USA is an equal opportunity employer, committed to the principles of inclusion and diversity for all employees and to providing employees with a work environment free of discrimination and harassment. 

All employment decisions at M3 USA are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical or mental disability, medical history or genetic information, sexual orientation, gender identity and/or expression, marital status, past or present military service, family or parental status, or any other status protected by the federal, state or local laws or regulations in the locations where we operate. 

All your information will be kept confidential according to EEO guidelines.

#LI-REMOTE

#LI-JD1