Sr Clinical Trial Manager. Spain. FSP

Sr Clinical Trial Manager – Spain

FSP Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success.

Job Responsibilities

• Manages geographical region(s) of a large complex clinical trial
• Independently manages all components of a small less complex study
• Has budget responsibility
• Manages cross‑functional timelines
• Applicable for biomarker operations
• Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
• Applicable for clinical operations Stockley Park and affiliate offices
• 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
• 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
• 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
• Clinical research organization (CRO) and relevant therapeutic experience preferred
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills
• Strong ability to manage time and work independently
• Direct therapeutic area expertise
• Ability to embrace new technologies
• Excellent communication, presentation, interpersonal skills, both written and spoken
• Ability to travel as necessary (approximately 30%)

Additional Information

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.

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.