Senior Manager Clinical Operations

This job has now expired please search on the home page to find live IT Jobs.

Global biopharmaceutical company focused on improving patients' lives through commercialising quality, innovative medicines prescribed by primary care physicians, specialists and those who treat patients with rare diseases.The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units. global headquarters are in Dublin, Ireland. The company also has offices in thePosition Summary: The Senior Manager, Clinical Operations will perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of the trial.Responsibilities:Facilitates and accelerates the development, execution, completion, and reporting of clinical trial(s) to meet or exceed the clinical development plan (CDP) and within budget and on time.Coordinates and contributes to designing, planning, development, monitoring and reporting of clinical trial(s) in accordance with company (or other applicable) SOPs, ICH E6 GCP, and other regulations and guidance as relevant. Support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP). Provide oversight of monitoring activities through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs.Primarily responsible for some or all study level deliverables including but not limited to: risk assessment, monitoring plan, study reference/procedure manual, pharmacy manual, template consent, data management plan, statistical analysis plan, safety management plan, etc. Review and refine Clinical Operations Plans/Vendor Oversight PlansEnsures that all staff (internal and external) assigned to a study are adequately qualified and trained and that the qualifications and training are documented and submitted to the Trial Master File. Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials. Facilitate training to clinical study teams on protocol specific topics.Qualifications and Skills Required:BS degree in related field, scientific background.6+ years' experience in pharmaceutical clinical research. Clinical trial management experience required.Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations.Package: competitive salary, bonus, shares, health and dental care, pensionFor immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales