Freelance Clinical Trial Manager - Eastern Europe - Oncology
Location | Europe |
Discipline: | Clinical Operations |
Job type: | Contract |
Salary: | £€ DOE |
Contact name: | Harry Henson |
Contact email: | harry.henson@rbwconsulting.com |
Contact phone: | +44 (0)1293 364 092 |
Job ref: | 2211HHCTM |
Published: | 20 days ago |
Duration: | 6 months |
Expiry date: | 22 Dec 2024 11:59 |
Startdate: | December 9th |
RBW Consulting are partnered with one of Europe's leading mid-sized CRO in their search for a Freelance Clinical Trial Manager to be based in Eastern Europe to work as a CTM in their Oncology function.
Start December 9th
0.8 - 1 FTE
6 month contract (initially)
Rate DOE
Extensive Oncology background essential
5+ years in a CTM or CPM role essential
Essential tasks include but are not limited to:
Primary clinical point of contact with the client
Collaborate with PM on monthly invoicing and variance management of clinical budget
Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
Generate potential site list from key stakeholders and drive site feasibility process
Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
Develop and finalize the country recruitment/retention strategy
Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
Lead internal clinical team meetings that are focused on the study related tasks and responsibilities and sets expectations for clinical team of CRAs and CTAs
Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
Support in planning and conducting investigator meetings
Review and/or approve of IP release packages
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
Responsible for eTMF implementation and management
Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
Work closely with PM for project-specific resourcing issues
Escalate pertinent CRA performance and site compliance issues when necessary
Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
Manage processes for investigational product (IP) including drug accountability and reconciliation
When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility when needed, as instructed
Supports business development and marketing activities as appropriate
May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
May perform clinical data review of patient profiles, data listings and summary tables, including query generation
Will not have line management responsibilities
Perform other duties as assigned by management
Apply here and Harry Henson will be in touch to discuss your application further!
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