Syneos Health
Website:
syneoshealth.com
Job details:
Description
Manager, Clinical Operations
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Job Summary
Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out. Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met. Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations. Supports senior management in operational level planning. May participate in business development presentations as a subject matter expert in Clinical Operations functions within the Company.
Core Responsibilities
- Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling May be involved in assignment of project work and will review workloads for all direct reports. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
- Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion.
- 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 work to ensure staff retention and turnover rates remain within expected levels.
- Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete required documentation. Provide regular updates to management accordingly.
- Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements. May provide business development support.
- May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed.
- Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution.
- Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance progress in line with departmental goals and metric targets. Oversee all quality control efforts of assigned teams.
Qualifications
- 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.
- Preference to have experience in the industry, managing clinical portfolios, and in clinical operations.
- Strong experience in Regulatory & Startup process.
- People management experience in managing 15-16 direct reports.
- Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements
- 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 modern technologies.
- Ability to travel as necessary (up to 25%)
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.
http://www.syneoshealth.com
Additional Information
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.
Summary
Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out. Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met. Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations. Supports senior management in operational level planning. May participate in business development presentations as a subject matter expert in Clinical Operations functions within the Company.
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