Responsibilities:

Lead the overall initiation, coordination, implementation, and management of the Material Acquisition Platform (MAP) program from start-up to closeout.
Lead the global study team dedicated to the study to ensure program goals and timelines are met.
Drive and manage relationships with internal stakeholders, KOL, surgeons, site staff and vendors.
Manage operational and technical aspects of the project including budgeting, study initiation and risk management.
Select, manage, and coordinate external vendors.
Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
Represent patient supply operations (PSO) on multi-function project teams internally and externally, report on study progress.
Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans.
Ensure the delivery of the study according to ICH GCP, local applicable regulations, and the company’s specific SOPs, where applicable
Provide operational input (and scientific if appropriate) into protocol synopsis, study protocol and all other study-related documents.
Design, review, and approve all trial-related documentation, and establish study processes.
Develop or review and support SOP development or update.

Education/Requirements:
[Bachelor’s degree (BSc, BA, or RN equivalent) in a biological or science-related field is essential.

4 years+ experience as a Project Manager in Pharma/Biotech preferred.
5 years+ experience in clinical studies
Experience in immune-oncology early phase and cell therapy desired.
Strong experience in global setting and matrix environment
Strong experience in partnering with diverse teams and delivering results through taking ownership of key programmed components.
Previous experience of sites monitoring in oncology studies
Strong clinical, technical or disease area expertise
Knowledge of medical terminology and clinical patient management
Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
Knowledge of ICH-GCP guidelines
Ability to manage multiple projects.
Excellent communication, interpersonal, collaboration and organisational skills
Effective problem-solving skills
Attention to detail and timelines.
Computer literacy, proficiency in Microsoft Office
Experienced with the use of eCRFs and eTMF.
Ability to work independently and to effectively prioritise tasks

Senior Manager, MAP, Patient Supply Operations