The PS is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving..
In partnership with sponsor enablement team, other sponsor clinical experts and external service providers, the PS provides oversight to ensure study delivery.
Leads / contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.)
Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’ / Monitors’ meeting)
Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate
Proactively contributes to risk and issue identification, development of mitigation and / or action plans for identified risks and issues
Ensures that all study documents in scope of Project Specialist responsibilities are complete and verified for quality in Trial Master File
Supports Project Manager / Project Leader with budget management, such as external service provider invoice reconciliation
Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH / GCP to ensure study is inspection ready at all times
Supports Project Manager / Project Leader in project management as per agreed delegation
For outsourced studies, supports Project Manager / Project Leader in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant sponsor SOPs and guidelines (e.
g. description of services and transfer of obligations)
Take on assignments on non-drug project work in process improvements and / or leading improvement projects as discussed and agreed upon with their manager
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Excellent verbal and written communication in English
Knowledge of clinical development / drug development process in various phases of development and therapy areas
Excellent knowledge of international guidelines ICH / GCP
Excellent communication and relationship building skills, including external service provider management skills
Experienced in supportive project management
Demonstrated ability to collaborate as well as work independently
Demonstrated leadership skills
Computer proficiency, advanced computer skills in day-to-day tasks