Project Manager I (Clinical Document Operations) - Serbia Remote Based - Medical Writing

Description
Project Manager I (Clinical Document Operations) - Serbia Remote Based - Medical Writing

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

• Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and Company's contractual agreement.
• Ensures the project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
• Providing support to coordination and governance activities related to acquisitions and divestment. Supporting the documentation of ClinDoc governance in collaboration with the hubs
• Supporting the initiative to create materials and approach on Driving the Evolution of a Unified GxP ClinDoc Culture Toward Inspection-Ready Excellence
• Supporting the preparation of future onboarding toolkits content
• May serve as the team leader by overseeing more junior project team members. Facilitates team building and communication.
• Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues.
• Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.
• Manages multiple projects ranging in size and complexity from single service regulatory/ medical writing projects to large full scope multi-year projects, global projects and/or programs, with minimal interaction from supervisor. This includes proactive operational and financial management of tasks, risk, escalations, and quality from start-up through final deliverable.
• Manages the executed contract and financial aspects of assigned projects/programs. Completes monthly review of tasks completed and backlog. Ensures customers are notified of out-of-scope items in a timely manner.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports. Ensures adequate documentation of each communication.
• Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.
• Networks to acquire new and/or repeat business.

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.

Summary
Ensures the contracted services and expectations of a regulatory and/or medical writing project are carried out by the Company project team in accordance with the executed contract and the Customer's expectations. Works in the role of a project manager on assigned project(s), which may range from single service to large full scope multi-year. Duties include primary liaison with Customers, Functional leads, Vendors, and Senior Management.