Syneos Health

Sr Project Manager/ Clinical Operations Manager - Sponsor dedicated Netherlands

Location
Home Based, NLD
Salary
Competitive
Posted
04 May 2021
Closes
03 Jun 2021
Ref
21005667
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Clinical Operations Manager - sponsor dedicated in Netherlands

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.

Summary

The Clinical Operations Manager responsibilities include leadership and local strategic planning and operational delivery of assigned clinical trials to support Incyte's pipeline, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Incyte SOPs, local operating guidelines and local requirements, as applicable. The Clinical Operations Manager works locally toward Global Operational targets for recruitment and completion of R&D sponsor trials within timelines and budget. In addition, the position requires management of local CRAs and local oversight of vendors.

Responsibilities
  • Has accountability and oversight for all assigned studies at country level in accordance with the overall plan and under the direction of the global team (Global Clinical Trial Manager) including adherence to quality, timelines and budgets.
  • Plans and executes country study goals and commitment, and ensures compliance to relevant processes
  • Collaborate cross functionally with Incyte country staff to build strong interaction at local level (e.g Medical Science Liaisons, medical team).
  • Representing the country and research Associates and provides Global team with feedback from a country perspective (Global Studies)
  • For in-house studies, working with the Study Start-up team, ensures timely submission of all regulatory, ethical and administrative submissions and helps to ensure their appropriate approval.
  • Oversees study feasibility, site monitoring performance and all relevant activities for assigned studies
  • Collaborates with the Global Study Team, and when necessary, develops and executes, the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan.
  • Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and implementation of Corrective Action Plan for assigned studies
  • Provides support to Clinical Research Associates (CRAs) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow-up to ensure team performance is fully optimized
  • Develops, builds and maintains optimal relationships with key institutions within the country, working closely with Medical Science Liaison/other local departments regarding site engagement strategy.
  • Ensures that clinical data from sites are delivered in accordance with established dataflow, timelines and quality.
  • Ensures that Incyte Clinical Trial Management System tracking tools and other systems are populated and maintained up-to-date for the country for assigned studies.
  • Leads and/or organizes and/or participates in local or regional meeting and training sessions to implement country level recruitment plans
  • Communicates regularly on country study(ies) status and escalates unresolved issues appropriately to the country Medical Affairs Director and/or ED, Clinical Operations and/or Global Study Team
  • Proactively incorporates learning and recommendation from study debriefs and best practices.
  • Maintains oversight and ensures consistency across studies within a project at the affiliate level.
  • Contributes to activities to improve and maintain quality and effectiveness of processes and activities within the function.
  • Makes an active contribution to therapeutic area strategy teams ensuring knowledge sharing of local interest.
  • Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Finance department.
  • If appropriate, review CRO monitoring plans and training plans for studies conducted in the country
  • Work closely and in collaboration with EU regional manager from Clinical Operation within Development Operations
What we're looking for
  • The position requires a minimum Bachelor's degree with 5-7 years of experience in Clinical Trial operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management.
  • Dutch speaker
  • Understanding of Dutch regulatory processes
  • Thorough understanding and experience in global/Regional clinical trials in oncology.
  • Good knowledge and experience of working with CROs
  • Matrix supervisory experience.
  • Demonstrated leadership and management skills.
  • Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel.
  • Proficient in Outlook/Word/Excel/PowerPoint.
  • Must be able to travel (domestic and international) up to 10%
  • Goal oriented, self-starter with proven ability to work independently;
  • Able to proactively identify issues and provide potential solutions for resolution;
  • Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and quality;
  • Ability to work independent as appropriate.


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.

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