Study Start-up Lead - Basel, Schweiz - CTC Resourcing Solutions

CTC Resourcing Solutions

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

The Life Science Career Network
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception.

The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a:

Study Start-Up Lead
for a 6 month-contract based in
Basel, Switzerland.

Main Responsibilities:

Planning and executing global study startup activities to ensure timely trial document and task completion to enable country Health Authorities and Ethics Committee submissions and site activation to meet recruitment plans;
Contributing to study startup insights to the development of the trial Operational Execution Plan;
Configuring and ensuring proper trialspecific setup of study startup systems;
Implementing global aspects of protocol and Operational Execution Plan amendments;
Ensuring timely collection global trial level document readiness and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation;
Supporting the Vendor Program Manager as needed;
Ensuring Protocol and Informed Consent Form global trial template is ready for country usage as necessary including translations;
Providing proactive oversight and risk management to achieve startup timelines and quality execution;
Providing oversight and support to country Study Startup Managers.

Qualifications and Experience:

-
Relevant working/residency permit or Swiss/EU-Citizenship required;:

Proven ability and strong experience in leading multidisciplinary teams in a complex matrix environment (including remote or virtual team environments);
High learning agility championing new technology platforms;
Strong problem solving, negotiation, deadline driven and conflict resolution skills;
Experience at handling high quality, timely study startup deliverables, documentation and data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP (Standard Operation Procedure) requirements.