About this role
TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.
The Evidence Delivery Director (EDD) will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs. The EDD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies).
In addition, the EDD will support BPM Evidence's continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials.
Usually, the EDD's focus will be on one of the three main types of work as described below:
Key Responsibilities
Company Sponsored Observational and Interventional Research:
Early input into evidence generation planning
Contribute to continuous development of Evidence Delivery
Input into Study Design Concept (SDC)
Accountable for protocol
Manage Study Governance (post SDC)
External Service Provider Management
Stakeholder Management
Manage study finance
Other Project Management activities
Externally Sponsored Scientific Research (ESR):
Governance - Delivery
Early Access (EA) /Named Patient Supplies (NPS):
Requirements
Bachelor's degree required preferably in medical or biological science or equivalent by experience.
Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
Scientific awareness and extensive knowledge of observational study guidelines and SOPs.
Extensive knowledge of early and late stage Pharmaceutical Development.
Ability to effectively work with Clinical Research Organisations/External Providers.
Proven ability to interact widely and effectively within the company across regions, functions and cultures.
Experience and knowledge within compliant management of Externally Sponsored Scientific Research.
Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment.
Open to periods of travel.
#J-18808-Ljbffr