Descrizione dell'offerta
Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system.
We are looking for a Clinical Trial Manger for a maternity cover.
The Clinical Trial Manager:
Directs and/or supports the planning and conduct of a clinical trial phase I to III, in-house and outsourced to a Contract Research Organization (CRO) in compliance with company processes, ICH-GCP and regulatory requirements;
Participates/directs CRO management and vendor oversight of outsourced activities;
Coordinates and participates in co-monitoring of clinical trials;
Performs assigned responsibilities to ensure timely achievement of departmental goals and objectives related to clinical trials.
Responsibilities
- Participates in the CRO selection process and periodic CRO/vendor performance assessment
- Contributes to development of clinical study protocols, trial budgets and project plans
- Contributes to country and site selection for clinical trials
- Assists in planning and operational execution of clinical trial supply needs
- Takes responsibility in maintenance of clinical trial registries and related databases
- Serves as point of contact to CRO and vendors
- Maintains a strong knowledge of the protocoland study procedures
- Reviews and prepares study plans and manuals (Patient Information Sheet and Informed Consent Form, Project Plan, Monitoring Plan, Communication Plan, Pharmacy Manual, Investigator Site File, etc.)
- Approves country/site PIS/ICF prepared by CRO and oversees timely PIS/ICF implementation on site level
- Develops and implements Vendor Oversight Management Plan (VOMP)
- Leads and/or supports preparation and conduct of bid-defense, kick-off, SMB and investigator meetings
- Ensures that essential documents are in place prior to site initiation and releaseof Investigational MedicinalProducts (IMP) to sites
- Conducts co-monitoring visits and reviews monitoring visit reports
- Develops study status trackers and reports
- Provides updates of study status to supervisor and senior management
- Ensures CRO and vendor oversight in compliance with VOMP
- Performs periodic review of protocol deviations, risks and issues to identifytrends, quality/compliance concerns or any other areas for improvement and initiates appropriate actions with CRO/vendor and as required in cooperation with CTL and/or Quality Assurance
- Participates in performance assessments, audits and Health Authority inspections
- Facilitates resolution of trial related issues through communication with site personnel and/or clinical trial vendors, including central labs, monitoring CROs
- Interact with internal functions to ensure appropriate performance in execution of delegated activities
- Set-up, maintenance and quality check of eTMF
- Support set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, RACT, etc.
- Set-up and maintenance of trial related Share Points
- Maintains knowledge of regulations, guidelines, policies and practices for clinical trials
- Participates in periodic review and development of corporate/departmental SOPs and policies
- Acts as Subject Matter Expert within Clinical Team as required
- Responds to stakeholder requests
Job Requirements
ProfessionalExperience
- Bachelor’s degree or equivalent qualification in life science/healthcare (Master’s degree is preferred)
- >5 years of progressively increasing clinical research experience within the pharmaceutical/CRO industry preferably in clinical operations in oncology
- Monitoring experience in oncology clinical trials
- Experience in management of clinical trials
- Experience with health authority inspections (FDA and/or EMA) preferred
Competencies & Personal Skills
- Thorough knowledge of drug development regulations (ICH-GCP, FDA, EMA and local regulations)
- Working experience in a global team, team player
- Strong interpersonal and leadership skills
- Excellent problem solving and team building skills
- Ability to work independently and in a team environment
- Good organizational and time management skills
- Ability to work under pressure and meet deadlines
- Good communication skills
- Ability to write in a clear, focused and concise manner
- Fluent in spoken and written English
As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us.
Nouscom is an equal opportunity employer. We welcome applications from all individuals. We are committed to treating all applicants fairly and avoiding discrimination.