Assoc Dir, Clinical Ops

Assoc Dir, Clinical Ops

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

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

Job Summary

Leads and manages Clinical Operations teams to ensure the timely delivery of high-quality clinical study activities in alignment with ICH GCP, client expectations, and company standards. Oversee operational performance, resource allocation, and quality outcomes while fostering staff development, stakeholder engagement, and continuous improvement. Provides training and consultation to support project deliverables and serves as the primary escalation point for resourcing, utilization, and performance matters. Collaborates across departments to optimize resource use, harmonize clinical operations processes and tools, and contribute to broader operational initiatives.

Core Responsibilities

• Line Management of Clinical Operations staff, responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/counselling of staff, including the management and development of other Managers, Clinical Operations. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.• Liaise with Resourcing management on active awarded and proposal project assignments. Review workload for all staff in reporting chain. Manage the resource availability for the assigned staff/country or 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, metrics compliance, and development of contingency plans, among others. Analyze performance and quality metrics to assure BU achievement of regional productivity and compliance metrics. Address improvement initiatives as identified.• Support the assessment of overall regional Clinical Operations staff growth and actively participate in the selection and hiring process. Proactively work to ensure staff retention and turnover rates remain within expected levels.• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete the required documentation. Provide regular compliance updates to management accordingly.• Oversee progress of teams supporting clinical projects. Ensure individual and team tasks are completed according to country/region specific and government regulations and per client expectations and contract. Support the management of customer relationships and escalate more serious issues as required.

• Work closely within appropriate business unit/country/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Ability to develop and oversee and provide direction to more junior managers in their reporting line, in the development of training plans and formal performance management plans for individuals to address performance deficiencies, when necessary.• Identify needs and may make recommendations for process improvement and efficiencies. Participate in committees and work groups to support the development and implementation of new initiatives and strategic direction of the BU and cross-BU Clinical Operations.• May provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. May participate in marketing activities, customer presentations and proposal development.

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.• Extensive knowledge of and experience with GCP/ICH guidelines and other applicable regulations.• Demonstrate strong leadership, tactical and strategic thinking skills. Demonstrate understanding of the workflow process, roles, and responsibilities of multiple functional areas. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.• Ability to understand, explain and communicate project concepts and put into detailed plans. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.• Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems• Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.• Ability to travel as necessary (approximately 20%)

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

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.