Single Sponsor - Clinical Project Manager II - Barcelona or Madrid.

Single Sponsor - Clinical Project Manager II - Barcelona or Madrid.

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

Management

• Mentors junior team members
• Manages Service Providers
• Task management may be required
• May contribute to employee performance management

Project Involvement

• Manages geographical region(s) of a large complex clinical trial
• Independently manages all components of a small less complex study
• Has budget responsibility
• Independently runs Phase 1 studies
• Manages cross functional timelines
• Applicable for biomarker operations
• Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
• Collaborates with local medical affairs colleagues on country specific studies and initiatives
• Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies

Key Differentiating Contributions

• Advanced project management skills adequate to manage the entire process of a clinical trial
• Ability to identify issues and adapt to changes.
• Ability to lead cross-functional teams internally and externally
• Mentors team members
• Ability to work independently with minimal oversight
• Will incorporate study logistics and planning to accomplish study objectives

Job Responsibilities & Skills

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Maintains study timelines
• Coordinates review of data listings and preparation of interim/final clinical study reports
• Assists in determining the activities to support a project’s priorities within functional area
• Contributes to development of RFPs and participates in selection of CROs/Service Providers
• May be asked to train CROs, Service Providers, investigators and study coordinators on study requirements
• Contributes to development of study budget
• May serve as a resource for others within the company for clinical trials management expertise
• Able to examine functional issues from an organizational perspective
• Participates in the recruiting and hiring process for CPAs and CTMAs and support their professional development
• May contribute to development of abstracts, presentations and manuscripts
• Under supervision, may design scientific communications within the company
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
• Must have a general, functional expertise to support SOP development and implementation
• Excellent teamwork, communication, decision-making and organizational skills are required
• Thorough knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Working knowledge and experience with Word, PowerPoint and Excel
• Travel is required

Qualifications:

• At least 5+ years of experience and a BS or BA in a relevant scientific discipline
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Experience in start‑up activities
• Strong ability to manage time and work independently.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.

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.