Associate Director, Clinical Trial Management - Root, Schweiz - Novocure

Novocure

Geprüftes Unternehmen

Root, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Location:

Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors.

TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death.

Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel.

Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

To lead a team out of Root, Switzerland we are looking for a

Associate Director, Clinical Trial Management

The Associate Director, Clinical Trial Management is responsible for independently overseeing all phases of global clinical trial management from initiation through closure, in accordance with applicable Standard Operating Procedures (SOPs), federal and local regulations, and ICH-GCP guidelines.

The Associate Director, Clinical Trial Management is responsible for oversight and leadership of the internal cross-functional Project Team conducting a clinical research trial, as well as the management of Contract Research Organizations (CROs) and other vendors, providing oversight of contracted deliverables and parameters.

The Associate Director oversees investigative site feasibility, selection and start-up, clinical monitoring and site management, medical monitoring, data management and biostatistics, safety, clinical records, medical writing, supply chain, regulatory submissions, and trial finances.

YOUR RESPONSIBILITIES:

Independently leads assigned clinical trials, Phases I-IV, for investigational devices in accordance with the Clinical Investigational Plan (CIP), applicable Standard Operating Procedures (SOPs), federal and local regulations, ISO standards, and ICH-GCP guidelines.
May assist in leading a therapeutic area program, ensuring operational consistencies across multiple studies
Leads internal and external crossfunctional Project Teams, overseeing daytoday operations, to achieve project objectives in alignment with corporate targets, i.e. enrollment, site activation, and financial performance goals
May be assigned as a Global Trial Lead, overseeing regional CTMs on global trials
Serves as the primary Sponsor point of escalation for all project/program stakeholders both internally and externally, including for CROs/vendors
Manages CROs/vendors, when services are outsourced, providing oversight of contracted deliverables and parameters; may serve as key member of governance or oversight committees
Accountable for project financial planning, management, and change control, including vendor contracts and budgets, change orders and amendments, invoice review, budget reconciliations and forecasting
Leads the selection and contracting of vendors, including reviewing Scope of Work (SOW) in collaboration with clinical procurement
Provides oversight of and drives project communications across functional areas, including regular status updates, project tracking, and project reporting
Collaborates with the CRO and Functional Leads to develop and evaluate Key Performance Indicators (KPIs) throughout the trial
Develops and manages the project timeline, forecasting and tracking milestones
Develops or oversees the development and implementation of crossfunctional clinical trial documents, including but not limited to: Protocols, ICF Templates, CRFs, study plans, manuals, sitefacing materials, and Clinical Study Reports (CSRs)
Oversees the development, maintenance, and final transfer of the electronic Trial Master File (eTMF); oversees routine TMF review
Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones
Oversees internal Project Team training and tracking of training documentation
Oversees risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses
Documents and escalates project and quality issues; initiates and conducts corrective/preventive actions as required
Collaborates internally to oversee clinical supplies and device management
Oversees protocol deviation management, including tracking and routine review
Participates in site feasibility assessment, potential investigator identification, and site selection
Oversees clinical monitoring and site management; reviews monitoring visit reports and conducts comonitoring visits
Participates in the development of site budget templates and reviews site contracts, budgets and invoices where required
Supports th