Senior Director Of Clinical Central Services

Company Description

About the Company: 

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 looking to hire a Senior Director of Clinical Central Servicesat M3 Wake Research. This position is a remote position with up to 20% travel .  

About the Business Division:

M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CRO's). 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 Senior Director of Clinical Central Services oversees and manages M3 Wake Research’s central service teams such as: study start up, budget/contracts, IRB submissions and approvals, and data management/ clinical trial management system (Clinical Conductor).  The Senior Director of Clinical Central Services will report to the Head of Clinical Operation in close partnership with Director of Clinical Central Services, Regional Directors, and individual Site Directors.

The mission of this position is to maximize the benefit and advantage of being a multi-location clinical trial site network by developing the most efficient and competitive central clinical functions.  We aim to have the fastest study start-up process, the best study budgets that maximize the revenue potential for each site, and the most efficient standardized processes that take full advantage of software solutions and technologies. The Senior Director of Clinical Central Services will drive our continuous improvement by establishing appropriate KPIs (key performance indicators) for each sub-function, setting up KPI targets, monitoring the progress, and implementing improvement ideas. 

The Senior Director of Clinical Central Services will partner with Site Directors to ensure that our Clinical Central Services team are providing the maximum value to their site.  When we acquire new site locations, the Senior Director of Clinical Central Service will work closely with the newly added site staff and integrate them into our existing system.

Essential Duties and Responsibilities:

Including, but not limited to the following: 

• Collaborates with the Site Director to maximize the overall service level of Clinical Central Services.
• Interfaces 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 Study Start Up and Enrollment; develops and executes contingency plans in order to keep the project on schedule.  
• Assists with the coordination of client meetings (PSV or SIV) 
• Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests. 
• Serves as a direct supervisor to budgets/contracts department to ensure negotiations are in line to achieve set profit margin goals.
• Serves as direct supervisor for source documentation team to ensure quality and timeliness of deliverables to sites so as not to negatively impact enrollment.
• Oversees tertiary operational elements to ensure all clinical trial elements are completed in a timely manner.
• Maintains communication between departments (Regulatory, contracts/budgets, source documentation) to increase efficiencies of trial execution.
• Oversee KPIs as they relate to study start up and budget/contract negotiation.
• Works closely with Clinical Operations to help streamline processes, create efficiencies, and oversee study start up and amendment processes.
• Ability to create, understand and be able to communicate competence gap analysis, and create personalized professional development plans. 
• Support the hiring, assessment, and development of staff in each functional area as needed. 
• Discuss the relationship and appropriate communication between Sponsor, CRO and PM/regulatory team. 
• Demonstrate the ability to lead and collaborate across multi-disciplinary and inter-professional research teams. 
• Demonstrate the ability to train, guide and support study team members on how to effectively communicate with various stakeholders in a manner that is relevant to the audience.
• The Senior Director of Clinical Central Services is directly in charge of our source documentation team, clinical trial agreement budget team, and CTMS data team.  Their peer will be the Director of Clinical Central Services who will be responsible for our regulatory and project management team. 

Qualifications

Requirements:

• Bachelor's degree or equivalent and relevant formal academic experience.  MA preferred.
• 3-5 years of relevant experience as a clinical research coordinator, site director or manager is required. Must have experience managing trials as it relates to study start up, IRB communications and budget/contract negotiations.  
• Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.  
• Strong written and verbal communication skills. An ability to consume, absorb, and analyze large amounts of information.  
• Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.  
• Strong computer skills in appropriate software and related company clinical systems are required.
• Exceptional time management, organizational skills, attention to detail and ability to multitask.
• Exhibit commitment to excellence and results by looking for and recommending and implementing process improvement from start to finish.
• Ability to lead creative strategies which motivate employees to drive business opportunities.
• The candidate must have well-developed analytical and problem-solving skills.
• Advanced project management and organizational skills, with motivation to achieve results with limited resources.
• Proven ability to plan and manage operational processes and streamline or implement processes that boost efficiency while supporting rapidly shifting business demands.
• Demonstrated interpersonal skills - effective listener with ability to engage with individuals at various levels with organization.
• Ability to positively adapt to change in a highly dynamic work environment and learn new processes.
• Expertise with Excel and project management software

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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