Clinical Project Manager, Biotech
|Contact Name:||Larry O’Leary|
Our client is a young innovative clinical stage biopharmaceutical company based in Dublin with a strong development pipeline, now have approval for a new permanent position for a Clinical Project Manager to manage the day-to-day activities of the clinical studies (Ph I-III).
You will be part of a highly experienced and collaborative team, who produce high-quality work in a fast-paced environment. This is a permanent full-time position, with flexibility to work remotely in Ireland while occasional visits to Dublin office for high-level meetings or events.
The successful candidate will work with the CRO to drive the scope of service agreements, budgets, plans and detailed timelines, ensuring that performance expectations are met and high-quality delivery of the ongoing clinical trials in accordance with SOPs, company policies and regulatory guidelines (ICH / GCP, etc.).
Person fit: the ideal candidate will be an experienced Clinical Project Manager, who is a dynamic individual, self-driven and capable of working on their own initiative in a young and growing company.
Responsibility for Clinical Project Manager:
Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
Accountable for successful study completion including clinical trial budgets and timelines.
Inputs to development of study documents e.g., study protocols, CRFs, PIs, ICFs, CSRs, sections for IBs and regulatory documents (e.g. IND, NDA, etc.).
Develops and progresses RFPs and selection and management of CROs/vendors.
Anticipates moderately complex obstacles and implements solutions to achieve project goals.
Resolves problems using national and international regulations, guidelines and investigator interaction.
Contributes to development of abstracts, presentations, and manuscripts.
Enable studies progression by ensuring compliance with relevant regulations and guidelines.
Manage the process to develop, review and contribute to Clinical activities.
Oversee planning and communication for investigator meetings and/or site and CRA training.
Perform financial management, including review and approval of site and vendor invoices.
Manage and support the vendor(s).
Oversight of the CRO processes and timely and quality filing of trial related documents/TMF.
Organise and manage internal team meetings, including trackers and follow up on actions and other trial-specific meetings.
Responsible for the development, review and implementation of departmental SOPs and processes.
Some EU travel e.g., site initiation visits, as required (circa 10%).
Requirements for Clinical Project Manager:
BSc or MSc with minimum of 5 years in Clinical Project Management experience, ideally on Phase I-III clinical studies.
10+ years' clinical operations experience, with progression from CTA to CRA and on CTM / CPM level.
Clinical trial management experience, including CRO/vendor management, monitoring of budget scope, and knowledge of all relevant clinical operational areas.
Experience in writing study protocols, study reports, etc. is preferred.
Experience working in multidisciplinary teams to set up, and conduct clinical studies.
Hands on experience of project management tools e.g. MS project and excel.
Proven ability to work under pressure to meet project deadlines.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Experience with clinical trial management systems, e.g. Docusign, Veeva Vault, etc.
Please contact 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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