Our client, a commercial stage Biopharma company with strong development pipeline, now seeks an experienced Clinical Project Manager to work within their Clinical Operations team based in Dublin.
This hire will provide oversight and vendor management for the successful management of all aspects of global clinical trials within designated program budgets and timelines.
The successful candidate will participate in devising strategy for qualification and selection of CROs for clinical studies. Furthermore, this hire will develop relationships with CROs to ensure that patient enrolment and data collection are completed in accordance with study timelines and objectives.
The ideal candidate will be an experienced Clinical Project Manager in successfully providing oversight of clinical trials; who has excellent teamwork, communication, decision-making and organizational skills and ability to work effectively in a dynamic environment.
Responsibilities of Senior Clinical Project Manager, Global role:
Work with the CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
Oversee clinical activities and quality by monitoring CROs through reviewing visit reports, protocol deviations, key risks and CAPAs; attend co-monitoring visits as required.
Enable studies progression by ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
Develop, review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, project plans and other study-related documents.
Coordinate / plan investigator meetings and/or site and CRA training.
Perform financial management, including review and approval of site and vendor invoices.
Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
Perform review and QC central clinical files and trial master file.
Identify potential study issues and recommend and implement solutions or corrective actions as needed.
Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
Organise and manage internal team meetings and other trial-specific meetings.
Participating in the development, review and implementation of departmental SOPs and processes.
Resolves problems using national and international regulations, guidelines and investigator interaction.
Participates in and/or leads departmental or interdepartmental strategic initiatives.
Requirements for Senior Clinical Project Manager, Global role:
BSc Degree as a minimum qualification. Advanced qualifications preferred.
5+ years pharmaceutical experience in designing/developing clinical studies, some of which in a Global Clinical Project Manager role.
Clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge clinical operations processes.
Experience working in cross-functionally teams to set up, and conduct clinical studies, preferable in the US and the EU.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
Proficiency in trial project management systems and MS applications including; Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
Effective communication skills via verbal, written and presentation abilities.
Ability to influence and negotiate.
For further details please phone Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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