Company: Docs Global (Continental Europe)
Location: Bad Homburg,Germany
Reference: Ref AS-019661
Closing Date: 04 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Our client, a research-based pharmaceutical company in Frankfurt is looking for a Clinical Development Consultant
Roles & Responsibilities of the position
• The CDC is the primary interface between the Company and investigators in aspects of Clinical Research. He/She partners with the TPO on interactions with investigators. The CDC is responsible for new sites-prospecting, for site identification and site selection during the FPA process. The CDC is accountable for delivering all regional, local, and corporate portfolio commitments/milestones for sites and trials within responsibility.
• Study feasibility, site feasibility, site identification (with CRPs) and site selection Clinical studies and Observational Research
• Deliver all regional, local, and corporate portfolio commitments/milestones for sties and trials within responsibility.
• Support local needs of globally outsourced studies within responsibility
• Manage IITs
• Regulatory submissions, in affiliates where this is managed by Clinical Operations
• Manage the allocation of patients within the geography
• Manage Site enrolment performance (Assist in recruitment planning, develop site level risk plan for enrolment, utilize available tools to assess site performance, collaborate with TPO CRA to enhance site performance
• Ensure the site ACDD (Anti-Corruption Due Diligence) process is followed and maintain appropriate Anti-Corruption certification of sites on file
• Primary interface with investigators
• Manage the link between site and the TPO
• Collaborate with partners, Quality, and other study team members to resolve/escalate site specific issues when necessary
• Organization & Function Profile
• Contribute to and partner with the local medical organization to deliver on department goals
• Manage and develop strategic relationship with current and future investigators
• Potential new sites-prospecting-seeking opportunities to widen future sites with portfolio needs
• Look for opportunities for Portfolio sites, Investigator Networks and Site Management Organizations (CMO)
• Master of Science or equivalent
• Knowledge of or experience of the local Healthcare system/model
• Deep scientific understanding / Therapeutic Area knowledge
• Strong, technical, operational Clinical Operations Expertise
• Willingness to travel to sites (appr. 60%)
• Fluent in English and German
• Personal strength and working style: precise, accurately, detailed, diligent
• Ability to collaborate effectively with multidisciplinary, cross-functional and international teams in a matrix organization, as well as to identify risks and develop mitigation strategies, anticipate and resolve issues in complex or sensitive situations
• Independently and proactive managing multiple responsibilities in a dynamic environment without close supervision
• Ability to monitor and escalate potential conflicts in submission deadlines and priorities to line management,
• Good interpersonal skills, excellent time management and organizational and managerial skills, service orientated
• Excellent verbal and written communication in English
• Proactive and flexible approach
• Proficiency in the Microsoft office suite
• Basic knowledge of database reporting tools and software, e.g. BusinessObjects, Access
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.
Interested? Please submit your CV to email@example.com. We are looking forward to your application.
If you have any questions, please feel free to give me a call : +49 89 24 440 7117
2 Globeside, Globeside Business Park
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