Mgr, Clinical Operations
Home-Based, United States
Posted on: September 21, 2022
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
• 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.
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%)
As a healthcare company we have an important responsibility to protect individual and public health. Except in those locations where state or local law impacts this vaccination requirement, this position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition, sincerely-held religious belief, or other reasons recognized by applicable law. Submission and approval of an exemption request does not necessarily guarantee that an accommodation can be provided for any specific job.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Posted on: September 21, 2022