Local Study Lead, Belgium - L

Employer
CROMSOURCE
Location
Belgium
Salary
Competitive
Closing date
4 Oct 2020

View more

Discipline
Clinical Research, Clinical Study Manager
Hours
Full Time
Contract Type
Permanent
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Description:
TalentSource Life Sciences, the division of CROMSOURCE and dedicated to flexible staffing solutions, is currently recruiting for our client, one of the world's largest pharmaceutical companies involved in a wide range of therapeutic areas. The company is located in Brussels, but has a very good work at home culture (4 days/week) to keep a good work-life balance. For our client we are looking for a senior profile with a flexible attitude and willing to work in a Start-up team. Presence at the office during the first three months is required for training purposes. A unique opportunity for Clinical Research Associates to evolve towards a Local Study Lead.

Position Purpose

The Local Study Lead acts as a subject matter expert on all start-up-related activities in the country/region, oversees and leads start-up activities in collaboration with other clinical research stakeholders.

Main Responsibilities and Accountabilities
  • Gain/maintain knowledge in protocol, monitoring manual, IMP and other relevant documents
  • Check prerequisites for a trial in preparation for pre study visits, initiations etc.
  • Arrange local meetings
  • Ensures cross-functional collaboration, e.g. point of contact for medical affairs regarding investigators, as applicable.
  • Be a representative for both internal and external communication
  • Support CML in inspections and audits
  • Propose Identify and propose national coordinator, appropriate trial sites and investigators for clinical studies
  • Provide input to the line managers of their study team members
  • Prepare and present trial information at internal and external meetings e.g. local investigator meetings.

In preparation phase
  • Participate in team meetings initiated
  • Ensure that local adaptations to monitoring manual are made (if needed)
  • Identify, select and manage vendors on local level
  • Maintain Trial Master File (TMF)
  • Ensure input is timely given for completeness of CTMS entries
  • Check pre requisites and prepare on-site logistics e.g complete IRT shipping forms
  • Collect essential documents for submission in collaboration
  • Preparation of local Subject Information (SI)/Informed Consent Form (ICF) and other required trial documents for submission, TMF and Investigator Site Files (ISFs)
  • Conduct and document Pre-trial contacts and support in site selection
  • Arrange supplies/materials etc
  • Provide site and trial information for budget and contract negotiations

In initiation phase
  • Ensure proper handover of trial to CRO-CRA
  • Participates in the Trial Initiation visit at site together with the CRO-CRA and ensures that the site staff is trained in protocol and related documents and procedures
  • Ensure that all essential documents are available before initiation, Maintain TMF up to date
  • Ensure input is timely given for completeness of CTMS entries

In conduct phase
  • Support CTA officer with adaptation of documents for substantial amendment submission
  • Adjustment of local SI/ICF and other required trial documents for submission (substantial amendment)
  • Support audits and inspections on site level


Qualifications
  • University Degree or Equivalent preferably in a medical/science-related field
  • Prior work experience as a clinical research associate, a minimum of 2 years of experience
  • Experience in start-up activities
  • Native Dutch or French and English
  • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country
  • Excellent communications skills in Dutch, French and English
  • Able to make effective decisions, self-motivated, assertive, and displays initiative
  • Demonstrated computer literacy, usage of MS Office software, web-based systems and databases
  • Experience in different therapeutic area's


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


Who will you be working for?

About CROMSOURCE

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.

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=HQ00002312

or please contact vanessa.verdickt@cromsource.com for more information.

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: Local Study Lead, Clinical Research Associate, CRA, Start-up, Feasibilities, Clinical Trials, Clinical Monitoring, Contract Research Organisation, CRO, Pharmaceuticals
Skills: Oncology, Clinical, CRO, EC Submissions, Feasibility, Monitoring, Pharma, Pharmaceutical, Start-up activities Location: Belgium Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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