Posted on Apr 3, 2021 by Real Staffing Group
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its orphan and inflammation groups. The global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
This position is responsible for assisting the Clinical Operations department with managing clinical trials, including onsite co-monitoring, as needed.
- Participates in the development, execution, completion and reporting of clinical trial(s) according to regulations, targets and within budget.
- Assists in drafting study related documents (protocol, informed consents)
- Assists in start-up activities of clinical studies including Investigator Meetings, selection of trial sites and investigators.
- Assist in managing CRO's/FSPs under the direction of study managers.
- Attend co-monitoring visits as needed.
- Reviews monitoring visit reports from CRO/FSP.
- Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.
- Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants.
- Writes, reviews and/or provides input to study plans and guidelines.
- Manages trial related materials and vendors, eg investigational product supplies, ancillary supplies, central laboratories, central IRB/IEC, etc. as assigned.
- Assists with the electronic trial master file (eTMF) processes including set-up and QC.
- Ensures the quality control of critical documents.
- Collaborates with CRO/FSP counterpart on an ongoing basis.
- Performs monitoring (PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 (R2) GCP and other regulations and guidance as relevant.
Qualifications and Skills Required:
- Degree in life sciences or equivalent and 4+ years' experience in clinical development and operations
- 3 - 5 years' experience performing on-site monitoring conducting SIVs, IMVs, COVs and/or co-monitoring experience for IND regulated clinical research studies
- Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations
- Demonstrated effectiveness in resolving site management issues of varying complexity
- Strong analytical skills
- Proficient in Microsoft Office
For immediate consideration apply with an up to date CV. Not sure yet? No CV ready please get in touch for more information?
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales