Ref #: 30118

Employment type: Fixed term - Full-Time

Location: the Netherlands

Posted: 07-Jul-2021

Description

Key Responsibilities:

• Primary point of contact between site staff and client . Acts as ambassador for the company and contributes to making the preferred partner.
• Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, NN procedures and protocol requirements to ensure data quality and study subject protection.
• Responsible for managing the site to meet patient recruitment rate and target.
• Delivers results that have direct impact on the successful completion of the clinical program.
• Coordinates with LTM and RTM and communicates to them progress and critical issues that may impair trial progress.

Main job tasks:

• Performing monitoring visits according to plan, document actions and follow up on action plans
• Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
• Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs)
• Train site staff in safety information handling and systems
• Know and meet all local and company requirements with respect to safety reporting
• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
• Identify potential risks and proactively take action to prevent or mitigate
• Collaborate with Data Management/logistics in resolving queries
• Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
• Manage trial product requirements, incl. temperature deviations and training of site staff
• Ensure collaboration with and deliverables from vendors locally, if applicable
• Collection and management of essential documents
• Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
• Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable





Additional requirements:

• Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)
• Timeliness in deliverables through process planning and goal setting
• Knowledge of IW/VRS functions, incl. training of site staff
• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
• Monitor and communicate internally any site observations critical to business results
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
• Support audits and inspections at sites and affiliate, as applicable
• Proficient use of Novo Nordisk systems (e.g. IMPACT, CATS, Investigator Portals)
• Ensure to list compliance/quality related tasks/responsibilities and specific, assigned acts of authority (QMS requirements) – also include information on independence and decision-making authority

Skills, experience and education:

• B.Sc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region
• Ideally experience from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO). Other experience may also be relevant, e.g. as study staff at a clinical research site.
• Ability to build and maintain relationships with sites
• Responsible and accountable
• Excellent communication and negotiation skills
• High focus on delivery and quality
• Adequate English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports
• IT proficiency
• Proven decision making and problem solving capabilities
• Ability to manage multiple priorities
• Team oriented personality with high degree of flexibility
• Ability and willingness to adjust quickly to new situations in a continuously developing environment
• High degree of trustworthiness
• Act as an ambassador for the clients values
• Flexibility is very important due to the large number of minor and major tasks coming from different customers

Why this vacancy is right for you:

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 iris.brouwer@docsglobal.com or apply via www.docsglobal.com. We are looking forward to your application!
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