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Regional Clinical Site Lead, Belgium - M

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
21 Sep 2022
Closing date
20 Oct 2022

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Discipline
Clinical Research, Study Site Coordinator
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Location: Brussels, Belgium - Office/Home-Based Hybrid Working

Schedule: Full-time, permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Regional Clinical Site Lead to join, our client is a global biopharmaceutical company that brings therapies to people that extend and significantly improve their lives through the discovery, development, and manufacture of healthcare products.

CROMSOURCE is an international CRO with a strong focus on quality, professional development, and supportive culture. 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 counterparts.

The Regional Clinical Site Lead will manage investigator site relationships to ensure effective delivery of clinical trials (study start-up, enrolment, database release), safeguard the quality of investigator sites (site health, patient safety), and maintain the Investigator/Study Coordinator engagement and satisfaction. In addition to ensuring the overall site quality, regulatory, and GCP compliance.

Main Job Tasks and Responsibilities:
  • Provide country/regional level input to country strategy, feasibility, and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.
  • Provide recommendations on potential sites and provide targeted follow-up with key sites as required. Influence the study teams in the selection of sites.
  • Oversee and support study start-up activities at the country level, including review of key documents: (local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.
  • Oversee and support study start-up activities at the site level, including management of emerging issues that may compromise time to site activation.
  • Provide enrollment support and ensure progress by responding to start-up and recruitment issues from investigators, partnering with the study team to define and support recruitment initiatives at the site/country level.
  • Lead effective site recruitment planning and implementation of plans at the country and site level, consistent with the global plan and local specificities.
  • Support database release as needed.
  • Be proactive in ensuring overall site quality, and regulatory and GCP compliance.
  • Support the study clinician in ensuring patient safety, and eligibility and providing clinical guidance to investigators and site monitors.
  • Provide protocol training to, and address protocol-related questions from, the investigator site staff, site monitor, and other RCSLs when required. This may include attendance at investigator meetings and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks.
  • Create and manage (the study oversight plan) and mitigate known/anticipated risks proactively.
  • Monitor site performance using appropriate tools and resources (metrics, site health, Risk-Based Monitoring signals, etc.) and take appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies.
  • Conduct and report oversight activities, both remote and onsite visits according to the standards.
  • Proactively identify, manage, and escalate site issues.
  • Help to address Significant Quality Events or other quality issues at the patient and/or site level.
  • Ensure resolution of investigator site issues in order to maintain sound investigator relations.
  • Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion.
  • Provide support for site audits/inspections as needed.
  • Maintain a thorough knowledge of assigned protocols.
  • Demonstrate TA/Category expertise where appropriate.
  • Demonstrates the learning culture by ensuring preventive actions are shared across assets in the portfolio to drive accelerated drug delivery.
  • Systematically applies site-level learnings from risk identification, mitigation, and control, across the trial and beyond (e.g., on asset level).
  • Drives continuous improvement initiatives and implementation within Global Conference on Sustainable Manufacturing (GCSM) and across Clinical Sciences & Operations to ensure successful trial delivery
  • Interface with the study team as needed and act as a representative of the Regional Clinical Site Lead function. Recognized historically as a critical contributor to the success of a study team.
  • Champion and ensure update of existing tools/processes related to clinical site selection and management.
  • As needed, facilitate the exchange of information to/from the study team on study progress and the impact of the local clinical development environment on the study/site
  • Provide regional and cross-regional insights on study-site performance and trends to/from the study team.
  • The Reginal Clinical Site Lead will represent the organization on the country level and/or acts as a delegate for the Director of Clinical Site Management.


Education and Experience:
  • A scientific or technical degree in the healthcare field, preferably a Ph.D./MD degree or master's degree with demonstrated clinical research experience.
  • Apply knowledge of data and analytics to the target site, study, and asset level actions for mitigation and control. Demonstrates use of these data to enhance quality and accelerate study delivery.


Specific Role Requirements and Skills:
  • Extensive knowledge of clinical trial methodologies.
  • Must be fluent in English French. Multi-language capabilities are an advantage in this role.


Our Benefits in Belgium:
  • Competitive Salary
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Dedicated Line Manager
  • Regular face-to-face or phone meetings with the 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 acknowledgment that we received it. If you have the requirements we need, you will be invited for a 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/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, 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 all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is 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 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: Regional Clinical Site Lead, Clinical Site Lead, Site Lead, Start-Up, Start-Up, Project Manager, Study Manager, PM, SM, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Skills: Start-up Manager, Clinical Research Organisation, CRO, Outsourcing, Project Leadership, Study Management Location: Belgium Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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