Clinical Operations Manager (FSP) at Syneos Health Clinical Solutions

Description

Manager, Clinical Operations 

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job responsibilities

• Line management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and employee counselling for staff.  May be involved in assignment of project work and will review workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Participate in managing the resource availability for the assigned staff/region, ensuring projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions. 
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively works to ensure staff retention and turnover rates remain within expected levels. 
• Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs. Ensures all staff follows required training and completes the required documentation.  Provides regular updates to management accordingly.
• Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors. Able to contribute to BU level process improvements. May provide business development support. 
• May conduct various types of sign off and assessment visits to ensure Clinical Operations on-site performance.  Develop and oversee training plans to address performance deficiencies.  Ensures staff adheres to training guidelines, training records are maintained and individual and corporate training needs are identified and addressed.
• Organizes and chairs clinical staff meetings at regular intervals. Manages issues and provides follow up for action items requiring resolution. 

Qualifications

What we’re looking for

• Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required. 
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
• Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Strong time management, technical and organizational skills. Ability to work independently and within a team environment. 
• Knowledge of basic financial concepts as related to forecasting and budgeting.  Understands project budgets.
• Must demonstrate good computer skills and be able to embrace new technologies 
• Ability to travel as necessary (up to 25%)