Location: Madrid or Barcelona, Spain
Closing Date: 31 Jan 17
Type: Full Time
Salary (£): On Application
Chiltern is Europe’s largest privately owned Clinical Research Organization, with over 40000 employees and 47 offices throughout Europe, both Eastern and Western, North America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones. The Chiltern Source department currently looking for a RCPN to work client based Madrid or Barcelona
• Responsible for protocol related targets, objectives and commitments regionally.
• Leads protocol teams to high performance; supports and interacts directly with CRAs to manage site level activities, interacts and communicates closely with CRM and COM for country timelines and deliverables, and escalates appropriately to CRD to drive efficient study start up, trial execution and closeout across the region.
• Responsible for meeting regional targets and objectives for assigned protocols. Drives and tracks protocol deliverables, timelines, trends and performance to meet regional commitments in partnership with countries. It is critical the RCPM manages trials proactively; identifies risks and opportunities early and lead, analyse and prepare mitigation plans and escalate to management. Examples of common problems include 1) low patient recruitment, 2) inadequate sponsor staff to meet business needs, 3) compliance issues and poor study quality, 4) regulatory issues, 5) availability of clinical supplies, and 6) issues related to functional area deliverables that could jeopardize protocol milestones
• Must make decisions independently to ensure trials are successful and executed in a compliant and timely manner, with support from regional leadership for key decisions (e.g. change allocation of patients in the region) to ensure regional commitments are met. Provides input to shape regional strategy
• Acts as primary point of contact between HQ and country operations in trial coordination and communication. Partners closely with HQ functional areas and builds meaningful relationships and networks. Requires careful coordination and alignment with the regional and broader organization.
• Interacts and communicates effectively in a culturally diverse remote virtual environment. Facilitates protocol-specific information sharing and best practices across countries. Provides protocol related training and expertise in the region.
• Coordinates protocol related HQ documents and oversees availability of HQ deliverables and supplies for countries. Collates CTA and other submission documents for the region as applicable. Updates and monitors clinical trial related systems and other protocol tracking tools as needed. Coordinates investigator's meeting activities.
• Builds a collaboration spirit in a virtual environment and across countries, cultures and functions.
~• Master of Science or Medicine (or comparable).
• 8-10 years clinical research experience. Extensive project management experience required.
• Expert operational knowledge of how clinical trials are conducted and strong scientific operational understanding. The position requires the ability to follow established processes and protocols and coordinate effectively with internal and external stakeholders.
• Proven extensive experience with project management with demonstrated success required. International experience will be valued.
• Excellent communication, educational/pedagogic, interaction, collaboration and organizational skills
• Strong ability to lead and coordinate protocol teams to high performance across the region. Requires that the individual has ability to work with a wide range of people across countries in a culturally diverse and remote virtual environment. Requires robust team building spirit with country operations.
• Ability to proactively develop risk management and mitigation plans across the region in an autonomous way to secure study success.
• Expertise in core systems and metrics. Requires ability to focus on multiple deliverables and protocols simultaneously.
• Ability to lead across several dimensions simultaneously.
• Ability to build understanding of country requirements to proactively serve and coordinate country needs specifically during study start up.
• Working knowledge of Client’s core business structure and how own function contributes to and works within the organization • Strong influencing skills
• Requires strategic thinking.
• Relationship management and networking: strong integration into headquarter network and ability to build productive relationships with all parties
• Ability to prioritize, align and simplify
• Fluency in English is required
• Has demonstrated the following leadership behaviours:
37 bis rue de Villiers, 92200 Neuilly sur Seine, France
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