Job Description

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
• M3is theonlycompany incorporated after the year2000to be included in theNikkei225 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 Project Manager - Site Startup at Wake Research, an M3 company. This is a remote position.

About the Business Division:

M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research is an integrated network of premier investigational sites working closely with and meeting the needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical industry, and clinical research organizations. M3 Wake Research has its proprietary patient database of potential clinical trial participants—men and women, children and adults, across all ethnicities—for all kinds of adaptive and other types of trial designs. Conducting studies since 1984, we have a combined subject database of more than 2 million.

M3 Wake Research has 26 owned and managed research sites across 9states in the US and continues to grow. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectations for integrity, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to regulations with superior quality.

Job Description

Mission:

Management of all aspects of Clinical Trial activities for assigned project(s). The Project Manager will work closely with internal and external stakeholders to support prompt delivery throughout the life cycle of each study project. Ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction.

Essential Duties and Responsibilities:

Including, but not limited to the following:

• Interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials.
• Identifies potential bottlenecks and/or delays in Start Up and Enrollment; develops and executes contingency plans in order to keep the project on schedule.
• Coordinates client meetings (PSV or SIV).
• Schedules and hold internal meetings to include but not limited to: Kick-Off Meetings (KOMs), and weekly calls for all M3 sites.
• Takes and shares meeting minutes.
• Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests.
• Keeps track and enters pertinent information such as study timelines dates in systems (CTMS, Salesforce, ShareFile), as well as department’s internal trackers.
• Review draft ICFs for all required elements prior to IRB submission.

Qualifications

Education and Training Required: Associate degree (2-year program) or equivalent level of education required; Bachelor’s Degree (4 year program) in a related field preferred.

Minimum Experience:

• 1-2 years or more of clinical research experience within a Clinical Research Site/Network or Contract Research Organization (CRO).
• Understanding of clinical research process and pharmaceutical development lifecycle.
• Experience with Salesforce and Clinical Conductor. Excellent oral and communication skills.
• Mastery skills in Microsoft Word, Excel, and/or other data management tools.
• Understanding of clinical and site logistics, as well as study start-up and site activation.
• Preferred previous knowledge with clinical trials CTMS (Clinical Conductor), Salesforce, and Florence e-regulatory portal.

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 to meet the business needs of the organization

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