- Role: Clinical Project Manager
- Location: Swedish Biotech, Remote from Finland
- Company: Immuno-Oncology Biotech
- Salary - Very competitive will discuss on application
Immuno-oncology drugs are one of the greatest medical breakthroughs of the 21st century, significantly improving cancer survival rates, with the global immuno-oncology market expected to reach $76 billion by 2021.
We are looking for a Clinical Project Manager to join one of our start-up Biotech clients in Sweden.
They are proud of their rich & developing pipeline which targets a high unmet need for novel immuno-oncology (IO) drugs. Their scientifically driven technology allows them to develop best in class therapeutics and continue to grow their portfolio to benefit those who are unfortunate enough to suffer from various cancer forms.
The company are progressing the clinical development of their lead phase I/II solid tumour molecule amongst other molecules in pre-clinical through to phase III. Their growth and development mean there is a need for an experienced Clinical Project Manager.
- Early- Mid-phase drug development experience (phase I-III)
- CRO selection & management
- 4+ years in clinical project/trial management
- Life Science Degree
- Vendor oversight experience
- Deep knowledge about ICH-GCP and other relevant regulation to conduct clinical trials
- Knowledge of IND/CTA submission to FDA and other competent authorities
- Experience of contract and budget negotiations with CROs, vendors, consultants and sites,
- Proficient in MS Word, Excel, Power Point, Outlook, MS Project,
- Excellent verbal and written communication skills in English
- Managing and leading all aspects of clinical study projects from study planning to close-out and study report,
- Selection and oversight of performance of Clinical Research Organizations (CROs) and other vendors
- Oversight and regular reporting of study progress to ensure successful completion within agreed timelines/ milestones and budget
- Study site selection and performance and participation in site visits (qualification, initiation, monitoring)
- Participate in establishing, monitoring, and maintaining procedures (SOPs) to ensure program meets all GCP/ICH Guidelines and is Inspection Ready,
- Support maintaining xxx relationship with KOLs and PI’s,
- Organizing and participating internal and external meetings as required,
- Co-development and review of study documents e.g., study protocol, informed consent form, monitoring guidelines, study manuals, Case Report Forms, regulatory authority submissions,
- Routinely review of study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies (e.g., reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals),
- Working closely with and cross functional teams at xxx (e.g., with manufacturing, pre-clinical, regulatory affairs, clinical pharmacology)
- Competitive Salary
- Flexible working environment
- Short communication lines and fast-paced environment
- Visibility and flat hierarchy
- Engagement with VP of Clinical Developmen
- Diversity of scope and responsibilities
- Remote working
- Will consider CRO/Pharma/Biotech candidates
Following your application Joseph Pearce, a specialist Clinical Operations Recruiter will discuss the opportunity with you in detail.
He will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can progress further to discussing other opportunities, which are also available right now or will be imminently becoming available.
Please click ‘apply’ or contact Joseph Pearce for any further information
Recruitment Consultant - Clinical Operations EU