Junior Clinical Project Manager

JOB TITLE
Junior Project Manager - London, England - Hybrid Office/WFH

JOB SUMMARY
I am looking for an individual with at least 3 years in clinical operations and 1+ years experience in clinical project/trial management. This is a hybrid role that will require you work in office 2 days a week (London Office). In this role you would be responsible for the management and delivery of woman's health centred clinical trials. My client is a global pharmaceutical company that works throughout the entire clinical development cycle. This is an exciting opportunity to rapidly expand your clinical trial expertise within a short time frame as you will gain exposure to a dynamic, matrix management structure that pushes for personal, professional growth. This is a contract to permanent opportunity as my client wants to on board a professional who is a great fit for the team, provided they are satisfied and motivated in their role within the company.

LOCATION
London, UK.

RESPONSIBILITIES

• Liaising with all relevant stakeholders including CRO's, CMO's, Investigators, sites and Pharmacovigilance providers
• Assisting in site selection, study implementation and ongoing co-ordination of study sites.
• Assisting in the drafting and review of non-clinical and clinical protocols, monitoring plans, regulatory plans, CRF's and CSR's
• Assisting in the preparation of regulatory submissions; CTA, IND, 510(k), NDA, MAA.
• Working within a cross-functional team.
• Managing and tracking confidentiality agreements and contracts with Vendors.
• Drafting Monitoring Visit Reports (MVR) and reviewing CRO MVRs. Assisting in preparation of safety, interim and final study reports, including resolving data discrepancies.
• Coordination of site visits, conducting independent monitoring visits and co-monitoring visits with the CRO Clinical Research Associate (CRA) and Project Manager.

REQUIREMENTS

• At least 1+ year's experience of clinical project/trial management
• Excellent communication skills in English - both written and spoken
• Entitlement to work in the UK
• Ability to work independently
• Exceptional communication, decision making and organisational skills
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
• Bachelor of Science/ relevant Scientific discipline or RN qualification

BENEFITS

• Working on cutting edge Woman's Health clinical trials
• Extensive internal training and development within project management
• Opportunity to develop skillset of managing clinical and non-clinical trials
• Flexible home based working
• Flexible FTE
• Small company - entrepreneurial environment

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Recruitment Consultant, Nicole Crowley on +44 (0)20 7551 0728, or email ncrowley@i-pharmconsulting.com. If this particular role is not suitable, Nicole is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
CTM / Clinical Trial Manager / Clinical Study Manager / Clinical Project Manager / CRA / CRA I / CRA II / Clinical Research Associate / SCRA / Senior Clinical Research Associate / Senior CRA / Clinical Monitor / Clinical Trials / Phase I / Phase II / Phase III / Phase IV / Good Clinical Practice / GCP / Oncology / CNS / Neurology / North West / Ireland / Leinster / Dublin / South East / Pharma's / Major Pharma's / Sponsor Pharma's / CRO / Contract Research Organisation / Pharmaceutical /Multiple Sponsors / Home Based / Study Start-Up / Feasibility / Site Identification / Site Initiation / Routine Monitoring / Close Out Visits /