Senior Study Project Manager
The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client, a dynamic biopharmaceutical company located in North Switzerland and focused on developing and commercializing small-molecule medicines for the treatment of cancers and immune-mediated diseases, is looking to recruit on a Permanent basis a:
Associate Director of Clinical Operations - 5078
The ideal candidate should have experience as Study Project Manager in a managerial or leadership role within Oncology, preferably Solid Tumors, phases 1 ? 3 and 4.
- Executing clinical studies in compliance with quality standards;
- Leading cross-functional study team; Leads Clinical Study Team Meetings; Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones;
- Responsible for regular updates to the cross-functional team and stakeholders on study status;
- Developing clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR);
- Managing study budget and overseeing spend against approved budget;
- Responsible for the vendor selection, scope development, management and oversight of external vendors in compliance with company processes and procedures and the applicable regulations;
- Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies;
- Proactively identify and address and/or escalate study-related issues and opportunities for efficiency; decision maker on operational aspects of study execution; participates in innovation and process improvement initiatives.
Qualifications and Experience:
- Bachelor?s Degree or equivalent degree is required;
- Must have at least 8 years of Pharma-related/clinical research-related management experience;
- Must have demonstrated a high level of core and technical competencies through management of clinical trials;
- Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4);
- Possess good communication skills and demonstrated leadership abilities;
- Demonstration of successful coaching and mentoring in a matrix environment;
- Considered a subject matter expert and competent in the application of Standard Business Procedures.
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