Description

Program Manager, Trial Master File (TMF) 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
• Participates in bid defense meetings and general capabilities presentations to grow TMF Operations Portfolio of work. Provides eTMF system demonstrations to perspective and existing clients.
• Evaluates and manages budgets across the portfolio to ensure appropriate TMF Operations revenue recognition is achieved.
• Implements processes and manages access/training for the company and/or client eTMF technologies.
• Develops portfolio level templates for TMF Plans and/or TMF related training.
• Presents and/or ensures TMF related training is effectively provided to the company, client and vendor project team members.
• Assesses and collaborates on resource needs for assigned portfolios.
• Collaborates with client to establish appropriate portfolio progress and business metrics to ensure TMF objectives are met.
• Oversees the portfolio level deliverables and KPIs.
• Liaises with the TMF Leads Management to ensure consistency on the TMF projects oversight, including projects performance and KPIs management across portfolios.
• Supports and mentors TMF Leads on TMF project oversight for assigned portfolio.
• Evaluates and documents potential TMF risks to their assigned portfolios and develops/implements mitigation strategies. Manages escalations by following the approved communication pathway informing TMF Operations Leadership and client, as applicable.
• Maintains effective communication with the client, Strategic Alliance Management team, TMF Operations team and project team through oral and written correspondence, portfolio level TMF Health KPIs reporting and Program Review Meetings ensuring adequate documentation of each communication.
• Prepares information for internal and client meetings. May attend Trusted Process event meetings, client operations meetings, project team meetings, and training sessions.
• Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
• Actively participates in professional organizations to keep abreast of best practices.
• Performs oversight, hiring, training and management of TMF Operations team members such as interviewing, selection and task management, as applicable.
• Minimal travel may be required (up to 25%). Performs other work-related duties as assigned.

Qualifications

What we’re looking for
• Undergraduate degree and experience managing a program/portfolio with direct experience managing client relationships.
• Moderate experience in a clinical and/or medical environment that includes working with regulatory records.
• Experience leading team members through direct or indirect line management preferred.
• Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
• Demonstrated leadership skills.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Proficiency in Microsoft Office Suite and email.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.

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
Bulgaria

Salary Criteria