Project Manager II

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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

Here at Syneos Health we are currently recruiting for a Clinical Project Manager II to be fully dedicated to our client, a global pharmaceutical company.

This position requires an experienced Project Manager, ideally within rare diseases as you will be aligned to this therapeutic areas. This is a great opportunity to work in a global team and leading the studies across Europe.

As a Clinical Project Manager you will be involved in all aspects of the daily operations of Phase I - IV clinical studies for assigned countries /sites, coordinating the initiation, conduct and close out of assigned studies on time, within budget and in accordance with country-specific regulations, as well as having regional management responsibilities

Job Duties & Responsibilities
• Accountable for all country deliverables including driving recruitment
• Act as country level point of contact for the site: develop and maintain productive relationships
• Provide feedback to Internal and External Stakeholders as appropriate
• Proactively oversee startup processes to ensure expeditious startup of studies. Work with CRO to overcome roadblocks and issues that may delay site initiation and activation.
• Manage the study feasibility process
• Develops close relationships with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Develop and maintain tracking tools
• Review ICF country adaptations, Ethics Committee and Regulatory questions to resolve issues locally.
• Reviews/approves budget within the framework.
• Works with local regional legal on contract negotiation (e.g.Clinical Trial Agreements, Pharmacy Contract, Loan Agreements.

#LI-NC1What we're looking for

• Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
• Proven experience with study start up activities
• Solid knowledge of clinical development processes
• Ability to lead, troubleshoot and influence for quality and delivery
• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
• Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
• Comprehensive and current regulatory knowledge, including GCPs
• Experience conducting GCP or other training is a plus
• Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 30% during busy periods)
• Good organizational skills and ability to deal with competing priorities
• Effective communication skills (written, verbal and presentation)
• Creative thinker, curious and unafraid to ask questions
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
• Proficient with MS Office Suite (Excel, Word and PowerPoint).

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.

#LI-NC1