Country-level Clinical Study Manager / Clinical Trial Manager
Our client is looking for a Clinical Study Manager/ Trial Manager with solid clinical trials experience who can handle complex studies as this operational role has broad demands. Ideally with strong UK-based complex clinical study management experience (I.e., oncology across phase II-IV or phase I to III).
Role and responsibilities
The successful person will also oversee some CRO clinical trials in different medical conditions as well as run feasibility in that therapy area. You will demonstrate proven track-record of getting clinical trials and studies on track and on time, a proven ability to interact with various departments and multi-disciplinary teams as well as excellent communication and leadership skills with the ability to bring studies and teams together.
- Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), Site Manager and Global Trial Manager. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
- Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
- Contributes input to the development of Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
- Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintains and updates trial management systems - (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress.
- Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection.
- May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
- Reviews and approves site and local vendor invoices as required
- Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- Act as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
- Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials.
- Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs.
- May represent functional area in process initiatives.
- Contributes to optimization of daily processes.
What is required
- A BA/BS degree is required. A degree in a health or science related field is preferred
- Strong pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
- Must have previous UK-based clinical trial/clinical study management experience with solid understanding of the drug development process including ICH/GCP and local regulatory requirements
- Good team player with excellent communication skills
- Candidates to start within 8 weeks preferred
- Part home-based but must be located within easy access to main motorway networks
- Ability to work with multi-disciplinary teams and departments with a real sense of leadership while being able to work as a team
- Full and valid UK working eligibility
- Full clean driving licence
What is offered
- Permanent contract of employment seconded to our client
- Training will be provided
- Salary will depend on level of experience and skills
- Company benefits to include 25 days’ holiday per annum plus UK Bank Holidays, car allowance, pension and private healthcare, etc.
Please send your application* with most recent CV in Word format to me.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.