Clinical Study Manager, Belgium – M
Job title: Clinical Study Manager, Belgium – M
Job description: Description:
Location: Ghent, Belgium
Schedule: Permanent – Full Time – Office based
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Study Manager (CSM) to strengthen the clinical team of one of our TOP Biopharmaceutical client Companies, specialised in antibody therapeutics.
As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
The clinical study manager is responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies. The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities. The CSM will be the “operational clinical study voice” for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track. The successful candidate will excel in establishing good and effective internal and external working relationships.
Main Job Tasks and Responsibilities:
The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:
- Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
- Leading CRO contracts negotiations together with the argenx vendor manager
- Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
- Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
- Ensuring that study Trial Master File is maintained and up to date
- Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
- Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
- Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
- Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
- Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
- Establishing and maintaining good relation with clinical site and study personnel
- Co-monitoring CROs personnel upon predefined plan
- Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed
- Leading and guiding the internal clinical study team and chairing study team meetings
- Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
- Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
- Ensuring that the assigned studies are executed according to the argenx quality standards
- Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
- Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative
The CSM will also participate in activities other than study-related which include but are not limited to:
- Providing input to the clinical development strategy/plan
- Co-writing/maintaining SOPs within the Clinical Operations department
Education and experience:
- Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
- Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
- Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
- Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
- Biotech experience is a plus
- Auto-immune and/or oncology clinical study background is a plus
Our benefits when working in Belgium:
- Competitive Salary
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Regular face-to-face or phone meetings with line manager
- Full annual performance review process
- Ad-hoc team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey – your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002558
please contact [email protected] for more information.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Clinical Study Manager, CSM, GCP, Auto-Immune, Oncology, Biotech
Skills: Autoimmune diseases, Oncology, Clinical Study Manager, Biotech, eCRF, GCP, ICH-GCP Location: Belgium Share:
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Job date: Fri, 21 May 2021 22:18:24 GMT
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