CROMSOURCE

Senior Clinical Project Manager, Belgium - L

Company
CROMSOURCE
Location
Belgium, Brussels Area
Salary
Competitive
Posted
21 Sep 2020
Closes
21 Oct 2020
Ref
HQ00002325
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, a division of CROMSOURCE, is currently looking for a Senior Clinical Project Manager to join our client-based team at one of the leading global biopharmaceutical companies. Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.

Scope of the role:
  • Accountable for the delivery of one or more studies (First in Human to Phase IV) from protocol through to study report and archiving.
  • Accountable for managing the interface between the client, Phase 1 Units, CROs and other vendors to ensure assigned studies
  • Accountable for leading Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads


Main tasks and responsibilities:
  • Coordination and communication within and across the company and CRO/Phase 1 Unit teams
  • At the study kick-off meeting study scope, goals and expectations of the client will need to be set with the CRO/Phase 1 Unit
  • Creates or contributes to detailed planning of the study timelines
  • Ensure that scope changes are tracked, appropriately endorsed and reflected in contract amendments
  • Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables
  • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and monitored
  • Understand, manage, track and ensure accuracy of study budgets in systems
  • Closely cooperate with relevant committees/governance bodies and/or CQA regarding the performance and quality of work received from the CROs/Phase 1 Units and other vendors
  • Work with CRO partners to define a study specific monitoring strategy Review Monitoring Plans and CRA generated reports
  • Support development of the clinical database, data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs); Data Monitoring Committee (DMC)/Safety Monitoring Committee (SMC)
  • Ensure that Clinical Study Reports (CSRs) meet the objectives of the trial
  • Support any audit/inspection activities and support CQA to ensure that result findings from audits/inspections are appropriately addressed in a timely manner
  • Visit investigational sites and Phase 1 Units to build and maintain relationships
  • Travel including overnight stays- possibly global - required


Requirements:
  • Bachelor's Degree
  • At least three years' relevant experience in clinical development including team leadership
  • Experience or capability to manage in-house and/or outsourced regional or global Phase I, II or III studies (First in Human to multicenter clinical studies) from study start-up to study report completion
  • A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end


Skills:
  • Clinical trial management in Early and Late Phase and team leadership
  • Motivation, mentoring and integration of individuals on multi-functional international teams
  • Delivery of scientific/medical presentations and training to both large and small audiences
  • Excellent verbal and written communication in English and good interpersonal skills
  • Proficiency in the Microsoft office suite
  • Excellent time management, organizational and negotiation skills
  • GCP and regulatory environment
  • Medical knowledge and research experience
  • Basic principles of data management and statistics
  • Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision


Our benefits when working in Belgium:
  • Dedicated Line Manager
  • Monthly meetings with line manager
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • Annual appraisals development planning
  • Yearly team event
  • New Year's diner
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement


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=HQ00002325

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: Clinical Project Manager, CPM, Senior Clinical Project Manager, SrCPM, Clinical Trials, Early Phases, BioPharmaceutical, Contract Research Organisation, CRO,
Skills: Neurology, Clinical Project Manager, Senior Clinical Trial Manager, Early Phase, Phase I, English Location: Belgium, Brussels Area Share:

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