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Job Details

Associate Director Clinical Trial Safety

Company: Docs Global (Continental Europe)
Location: Warszawa,Poland
Reference: Ref AS-022314
Closing Date: 27 Sep 17
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS is supporting highly prestigious and one of the world’s top pharmaceutical company that is bringing innovative ideas, products and services continuously improving people’s health. This is a fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture in vibrant Client's office in Warsaw.


Roles & Responsibilities of the position

The Associate Director Clinical Trial Safety (ADCTS) is a management role within sponsor’s Global Medicines Development Clinical Operations reporting directly the head of the Global Center for Clinical Trial Safety Data Review (GCTSDR). The individual will lead and manage teams of Clinical Trial Safety Specialists and Associates who are responsible for reviewing important safety data during the course of late stage clinical trials in Global Medicines Development (GMD). The ADCTS must be science-driven individual with relevant therapeutic area experience (i.e. Oncology, Immuno-oncology, Respiratory, CVMD, etc.).

•Accountable for Clinical Trial Safety Specialists & Associates performing the review of critical safety data for medical completeness and medical accuracy
•Contribute to study start-up activities such as the generation of the Safety Management Plan and Safety Handling Plan
•Work collaboratively as a member of Clinical Operations
•Support the Senior Director to forecast resourcing, utilization, and functional budget
•Assist with recruiting and retaining talent, including building effective teams and people that support and complement each other
•Align with the respective Therapy Areas (GMED) to establish standards for important safety data review, quality metrics including aggregate safety reports and patient narratives
•Ensure and maintain appropriate training for self and staff for relevant Pharmacov

Job Requirements

•Medical degree and experience in patient safety or pharmacovigilance preferably in relevant therapeutic area
•Minimum 8 years of experience working on clinical studies and/or pharmaceutical development across multiple therapeutic areas
•Clinical Operations experience within the therapy area of interest
•Experience as a line manager with a track record of developing direct reports in their professional growth
•Extensive knowledge of applicable regulations and guidelines, including SAE reporting requirements
•Risk management experience
•Ability to manage change
•Creativity, innovation, and results-oriented
•Ability to set and manage priorities, resources, performance targets, and project initiatives in a global environment
•Excellent stakeholder management skills
•Proven organizational and analytical skills
•Adept at building and leading presentations
•Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
•Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
•Good understanding of clinical data flow
•Computer proficiency
•Excellent knowledge of spoken and written English

Remuneration & other details

Our client offers the following benefits:
·Company car
·Annual bonus
·medical care for employee (Luxmed)
·life insurance (incl. hospitalization)
·credit card for lunch purpose
·social fund (vacation allowance, Multisport card)
·pension plan (4% of monthly salary, starts after 1 year of service)
·additional education refund (English, postgraduate) after 3 years of service
·jubilee award (5,10…years of service)

To apply:
For an immediate consideration please contact Dagmara Drozdowska on: +48 668 87 02 61or email your CV (WORD file) to:

Apply for this job: Associate Director Clinical Trial Safety

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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