Company: Docs Global (Continental Europe)
Location: New Brunswick,Netherlands
Reference: Ref AS-019870
Closing Date: 06 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Are you interested in this postion? Please contact: Iris Brouwer firstname.lastname@example.org 06-51129787
Roles & Responsibilities of the position
Develop a Project Plan based on the SOW for tools and tactics for a clinical trial as developed by the Strategic Recruitment Manager.
• Manage execution phase of project:
o Go to contract with vendors, as defined in SOW, with the help of Janssen R&D Procurement (JRP) and once a contract is obtained, go to PO
o Provide the development of tools and tactics as listed in the SOW, including the content writing or the liaising with a vendor for content writing
o Oversee the translations of tools and tactics as listed in the SOW
o Facilitate the applicable central J&J compliance review process of tools and tactics; obtain and document the compliance approvals
o Obtain and document local approval of tools and tactics by the local trial team
o Obtain and document IRB/EC approval of tools and tactics, if needed
o Manage the execution or the printing and distribution process of the approved tools and tactics
o Manage the vendors involved, set clear expectations with the vendor regarding deliverables, timelines, costs, communication pathway, etc.
o Control the timelines to meet the local submission process
o Track the costs of the vendors involved and provide regular spending updates to the Strategic Recruitment Manager.
o Execute different scenarios in recruitment tools and tactics management: amendments, rescue missions, added countries and sites, adaptive design, non-template requests, as defined in the updated SOW.
• Serve as the liaison between the clinical trial team and suppliers, as appropriate.
• Participate in critical study-related meetings, i.e., Study Management Team (SMT) meetings
• Escalate implementation issues as defined by the departmental business processes
• Maintain a library of tools, tactics and templates on the GCO portal, as well as FAQs regarding the deliverables
At least 3 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO.
• Expertise in the areas of drug development, clinical trial operations, and strategic planning.
• Previous experience in clinical trial operations including the execution of study outreach, patient compliance and study support programs.
• Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects.
• Excellent time, priority, and self management skills. Strong project management skills.
• Strong team orientation; demonstrates initiative to solve problems and improve efficiency and/or customer service.
• High-degree of proficiency in Microsoft Excel, PowerPoint and Word. Bachelor’s Degree or equivalent, preferably in a scientific or health-related discipline
The position is primarily accountable for the management, execution and timely delivery of tactics for patient and site-facing initiatives for a clinical trial as defined in the Statement of Work (SOW) developed by the Strategic Recruitment Manager. Tactics include, but are not limited to: patient recruitment, retention or compliance; Informed Consent; or site engagement.
2 Globeside, Globeside Business Park
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