Description

Associate Director, Clinical Delivery

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

Provides leadership, direction and management to assigned book of work/studies.  Provides operational oversight and guidance to staff to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others.   Acts as a point of contact for delivery strategy and solutions around site activation readiness, monitoring , enrollment and/or site management; including alignment both internally and externally for assigned studies.   Provide Delivery Oversight to support quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP for assigned portfolio.  Works closely within appropriate business unit/region to ensure staff performance on studies and ensure correction of any deficiencies as identified by staff, clients, and auditors.    Develops and/or supports customer relationships, manage customer expectations, governance structures, process standardization, and escalates more serious risks and issues as required.            Oversees assigned book of work/studies to ensure identification of critical data and process, the assessment of risks to protocol execution and clinical delivery.  Identifies needs and may make recommendations for process improvement and efficiencies.  Participates in work streams to support the development and implementation of new BU /cross functional strategic initiatives.   May be required to validate ( timing & forecast) hours applied in the designated resourcing tool where functional staff are not yet assigned. Uses data-analytics to oversee clinical delivery services, operations, compliance and quality. Ensures issue resolution for site activation readiness, monitoring strategy, enrollment and/or site management.  Supports financial oversight of assigned book of work related to site activation readiness, monitoring, enrollment and/or site management to achieve target revenue. Support in audits of clinical delivery and prepares others for participation in audits. Provides 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, client presentations and proposal development.

Qualifications

What we’re looking for 

Bachelor’s degree or equivalent combination of education, training and experience plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. Master’s degree or life sciences degree preferred.  Must have demonstrated proficiency with ICH/GCP guidelines, site activation, enrollment, monitoring and/or site management procedures. Demonstrated ability to manage multiple tasks within a dynamic matrix team environment is essential – all while assuring portfolio delivery on time and with quality. Familiar with project risk and issues management. Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner.  Experience interacting with key stakeholders and sponsors, including experience handling conflict and difficult conversations. Ability to persuade and influence at all levels, demonstrate strong negotiation skills, organizational skills and problem-solving skills. Comfortable making tough decisions. Demonstrates ability to oversee financial health as related to forecasting, budgeting, and proposal review. Requires strong presentation, written and verbal communication, documentation and interpersonal skills as well as a team-oriented approach.  Proficiency in Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint, etc.) Demonstrates ability to leverage Analytical Data Visualization Tools to drive performance, operational efficiency and decisions. Knowledge of Lean Six Sigma preferred. Demonstrated strong leadership, tactical and strategic thinking skills. <30% travel may be required (departmental meetings, investigator meetings, training, client meetings and bid defenses)

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.

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.