Clinical Trial Manager The Netherlands

2 weken geleden

Amsterdam, Noord-Holland, Nederland Pharmiweb Voltijd


For one of our FSP clients we are currently recruiting for a Clinical Trial Manager. This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
For certain studies, the CRM could be responsible for several countries in a cluster.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • 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
  • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
    • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
    • Performs Quality control visits as required
  • Leads local study teams to high performance: trains in the protocol for other local roles, collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs, and COM)
  • Responsible for creating and executing a local risk management plan for assigned studies
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
  • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
  • Identifies and shares best practices across clinical trials, countries, clusters
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
  • Country POC for programmatically outsourced trials for assigned protocols.
  • As a customer-facing role, this position will build business relationships and represent MSD with investigators
  • Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
  • Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
  • Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
  • Lead and contribute to initiatives and projects adding value to the business and supporting the strategy

Qualifications

What we're looking for:
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • 5-6 years of experience in clinical research, CRA experience preferred.
  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
  • Requires strong understanding of local regulatory environment
  • Strong scientific and clinical research knowledge is required
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Experience functioning as a key link between Country Operations and Clinical Trial Teams
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
  • Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
  • Proficiency in written and spoken English and Dutch. The incumbent must be competent and effective in written and verbal communication.
  • Strategic thinking
  • Ability to work efficiently in a remote and virtual environment
  • Understand Cultural Diversity
  • The position requires proven strong project management skills

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.

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