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Careers in Belgium
DEVELOP YOUR CAREER WITH PPD
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| Project Assistant / Reasearch Assistant |
As a Project Assistant or Research Assistant you will provide vital support for clinical research projects. You will have excellent communication and organisational skills and a self-motivated, flexible, and professional attitude. You must be able to prioritise and work well within a multi-national team environment and have an in-depth knowledge of Microsoft Word, Excel and preferably PowerPoint.
As a Project Assistant you will have a good standard of education and two years administration experience.
Research Assistants will have a life science/nursing qualification and at least six months administration experience. The Research Assistant role will provide the training required to progress and become a Clinical Research Associate. |
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| Associate Director, Clinical Data Management - Brussels |
Supporting the Vice President, Clinical Data Management you will provide management and support to all data management processes, ensuring all projects are conducted in accordance with sponsor requirements and PPD Standard Operating Procedures and within budget.
Duties and Responsibilities (according to relevant guidelines, laws and SOP’s):
- To provide general support to the European Vice President of Data Management in Europe overseeing and developing data management staff
- To participate in the formation and implementation of the strategic development plans for data management both within Europe and on a global basis.
- To support department structure through leadership of various functions within the department.
- To participate in executive review meetings and deputise for the Vice President of Data Management when required.
- To be able to identify improvement opportunities, devise a strategy and implement the necessary tactical activities to achieve the strategy.
- To ensure adherence to Company and Department policies and procedures with the group.
- To act as Line Manager to a group of Group Leaders across Europe and work on their continued development.
- To ensure that all Line Management Team work to the latest Global SOPs and WPDs and to ensure that all Line Management Teams are appropriately trained in these.
- To ensure that for each Line Management staff member that there is a training plan in place.
- To ensure that there is regular review of each individual member of the team. This should include and assessment of each individual’s contribution, their key responsibilities and training needs. In addition, to ensure that all required steps are taken to deal with non-performance of the Team as a whole, in order to identify areas where quality, efficiency and individual performance can be developed and improved.
- To manage all aspects of data management for groups of assigned clients and projects. This includes ensuring the creation and maintenance of detailed project plans for DM aspects of projects.
- To identify resource requirements by staff type at project set-up and for the duration of the project, and to ensure that the resource is in place for all assigned projects.
- To ensure that for all assigned projects the DM tasks are completed accurately, on time and within budget.
- To act as the senior contact for all aspects of data management for assigned clients and projects. This includes effectively liaising with/meeting Sponsors, Project Managers and internal department staff over progress and any technical issues.
With a Life Science Degree or equivalent you will have a minimum of 8 years experience of Data Management in the clinical research field, including 5 years management experience. An excellent track record in Strategic Management in a Data Management role is preferred, including driving the management of change to raise the performance of a Data Management activity to the highest level. Planning and budgeting experience at a senior level is a key requirement.
For more information or to apply for this position, please send your CV and covering letter in Word format to recruitdm.sm@europe.ppdi.com
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| Supervisor, Investigator Services - GCL |
This person ensures efficient and effective operations in the department, coordinates the team and recommends candidates for hiring, termination, prepares and conducts performance appraisals and salary reviews, and applies company policies. The position is responsible for the overall performance, education, support and training of the sites to ensure that protocols are completed accurately and on time.
The Supervisor is an expert in using the computer system and provides guidance to the Investigator Services Assistants and Data Entry Assistants, if required. He/she is responsible for training all Investigator Services Assistants and for writing all the necessary procedural and training documents. Attends study protocol meetings and educates staff on protocol issues requiring attention. Overall view and site performance to meet the timelines and execution of the protocol to ensure clean data at the earliest time point. He/she is responsible for ensuring all calls to the sites delivering sponsor alert, voice alert values (VAV) and any other critical values. He/she is responsible for incoming phone calls, resolving different types of exceptions within assigned timelines and other duties as assigned or required.
In conjunction with the manager of Investigator Services, he/she will set and evaluate performance metrics.
This person ensures efficient and effective operations in the department, coordinates the team and recommends candidates for hiring, termination, prepares and conducts performance appraisals and salary reviews, and applies company policies. The position is responsible for the overall performance, education, support and training of the sites to ensure that protocols are completed accurately and on time.
The Supervisor is an expert in using the computer system and provides guidance to the Investigator Services Assistants and Data Entry Assistants, if required. He/she is responsible for training all Investigator Services Assistants and for writing all the necessary procedural and training documents. Attends study protocol meetings and educates staff on protocol issues requiring attention. Overall view and site performance to meet the timelines and execution of the protocol to ensure clean data at the earliest time point. He/she is responsible for ensuring all calls to the sites delivering sponsor alert, voice alert values (VAV) and any other critical values. He/she is responsible for incoming phone calls, resolving different types of exceptions within assigned timelines and other duties as assigned or required.
In conjunction with the manager of Investigator Services, he/she will set and evaluate performance metrics.
For more information or to apply for this role please send your CV in word format to Viviane.Bleus@mrli.ppdi.com
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| GCL Project Management - Study Manager |
As a Study Manager you will be responsible for the successful delivery of global laboratory services, from protocol interpretation to investigator supply chain mechanisms.
You will:
- Set up and manage clinical research projects within our laboratory.
- Coordinate site supply according to a priority listing form sponsor at study start and subsequent re-supply of sites.
- Develop and prepare protocol specific reports.
- Create, compile and translate labratory manuals and information documents.
- Establish quality assurance indicators and monitor outcomes for various resource components of the clinical study process.
Study Managers will be life science graduates or equivalent, with two years experience in project management gained in clinical trial supplies, preferably on an international basis.
All applicants will be team minded but able work individually, with strong communication and interpersonal skills. Although we would like people to have a fluency in English both written and spoken and good knowledge of any other european
language would be an asset. |
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| GCL Set-up Administrator |
This position is solely responsible and accountable for ensuring that all physical study setup documents and materials provided to the investigator sites are created correctly according to specifications. The Setup Administrator participates during the study set up phase defining and creating the study specific documents. The incumbent uses dedicated software applications to create the study labels and requisition cards, the investigator manual, investigator meeting presentation, visit specific kit definitions (specimen containers and ancillary materials), and any other study related documents. He/she works with Investigator Services to ensure they enter and check sites information and that sites are ready to receive services for the assigned studies. The Setup Administrator provides finished product specifications and sites ready to the Project Manager within specified timelines for approval and release to production by the according operating functions (in particular Supply Chain).
This position will perform required tasks for 5 to 10 projects at any given time using multi-tasking skills on a regular basis to manage these activities. Reports study setup performance metrics on a regular basis to the Project Manager or Project Account Manager.
This position is accountable for client satisfaction by meeting study specifications and setup timelines for assigned study deliverables.
For more information or to apply for this role please send your CV in word format to Viviane.Bleus@mrli.ppdi.com
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| GCL Project Account Manager |
This position is accountable for global sponsor satisfaction & success ensuring that all GCL-managed projects and programs meet their targets (timelines, specifications/quality and budgets) through our corresponding PMs and that the key accounts receives a superior level of service from sales to invoice to the next program award.
The Project Account Manager acts as a consultant and GCL service expert providing valuable information in RFI/RFP or during capabilities presentations. He/she sells the business from inside by providing and ensuring quality and customer-aligned service and serves as a spokesperson to Business Development.
He/she performs feasibility assessments, identifies & analyzes the client needs vs current capabilities and provides scientific, technical and operational input to design and implement protocol- and account-specific solutions to successfully win and efficiently conduct these projects.
The Project Account Manager acts as a mentor for junior team members and promotes strong team approach for assigned projects. He/she acts as an escalation alternative for sponsor CTL or Outsourcing staff and PPD GCL Project Managers.
Outcomes of this role are a significant increase in account satisfaction, new business (awards) and revenues.
- Requires 15-20% travel (US and International) that may occur on the weekends
- Based on workload, acts as a PM up to 40% of time.
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| Programming Analyst |
As a member of the Programming team, you will provide Oracle Clinical database and programming development/support to our European Data Management group on a variety of systems across multiple platforms. Working alongside clients on varied projects you will be an integral member of multidisciplinary project teams. The continued growth of the team will generate opportunities to contribute to various departmental programmes including process streamlining and tool assessment/development.
You will need a team-oriented approach along with strong communication skills and an ability to produce high quality work within tight timelines. Experience of working in a clinical research environment would be advantageous, though strong candidates with transferable skills will be considered. A degree in computing or a related field is required and relevant experience in Oracle Clinical or SAS ? is desirable.
We offer excellent training and career prospects, competitive salaries and a range of benefits.
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| Project Management Opportunities |
Our sustained year on year growth at PPD means that we are looking for Project Managers to join our rapidly growing teams at our offices in Cambridge, Glasgow, Winchester, Brussels, Paris and Munich.
What is most significant about our recruitment activities is the breadth of project management experience we’re looking for. We need individuals with varying degrees of experience to take on European and Global project management, programme management and product development roles.
Our Project Managers lead and are accountable for time, cost and quality targets and resource and budget control. To achieve this, candidates must not only possess the appropriate project management experience but also the drive and enthusiasm to share and apply their knowledge to the diverse and challenging projects we manage for our clients. In return, you will have excellent career opportunities and Project Managers who fit the required profile can benefit from the option of being home or office-based. |
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| QA Manager - Brussels |
Your primary responsibilities will be to schedule and conduct audits for a range of PPD?s clients and to perform internal facility and system audits across all PPD operations. You will have interactions with key players and operational managers, and represent the quality function to our clients. As a senior member of the group you will mentor auditors and assist the Executive Director with planning of audit programmes, review of results from all audit types and recommend improvement strategies. You will also play a key role during client audit and regulatory inspection activities.
You will need a passion for quality combined with excellent communication and interpersonal skills. You will be a life science graduate with at least five years' experience of multi-national clinical studies in pharmaceutical or CRO business environments and four years? experience in Quality Assurance.
All applicants will require a working knowledge of the background and application of GCP, basic business computer skills (MS Word, Excel, e-mail, etc) and a full driving license.
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| QP/Regulatory Affairs Manager - Brussels, Belgium |
Due to an increase in business we are looking for a QP/Regulatory Affairs Managers to be based in our offices in Brussels. Responsibilities will be in relation to the release of an investigational medicinal product, placebo or comparator for a defined clinical study and the provision of expert regulatory advice and development of regulatory strategies, creating and reviewing submission documentation, compilation of submission dossiers and ensuring timely submissions in Europe, South Africa and the Pacific Rim.
This may include the set up and review of Quality Assurance Technical Agreements with the Trial Sponsor, performing audits of GMP facilities, set up and maintenance of Product Specification Files (PSF), release and maintenance of a register of all medicinal product batches to be used in a clinical study.
You will manage multiple projects in the provision of regulatory affairs services which will involve liaison with internal and external clients, co-ordination of local regulatory affairs staff and provision of regular submission status updates.
A key aspect of your role will be to provide support, training and management of other regulatory affairs professionals and to develop and ensure compliance with departmental work practices. Other aspects include assisting in business development activities, pricing of projects and budgeting for Regulatory Affairs in the company.
You will have a broad range of Regulatory Affairs experience gained within the CRO or Pharmaceutical industry and be able to demonstrate extensive knowledge of Regulatory Affairs in Europe especially the UK and/or European Clinical Trials procedures. Previous managerial or supervisory skills would also be an advantage
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| Regulatory Affairs Manager - Brussels |
Due to an increase in workload we are looking for a Regulatory Affairs Manager to be based in our office in France. You will be responsible for providing timely, accurate regulatory advice on strategy and will manage projects in the provision of regulatory affairs services. This will involve you liaising with internal and external clients in the provision and marketing of these services.
A key aspect of your role will be to take primary responsibility for effective interactions with the French Authorities to support local/central functions and assigned activities. You will also be expected to build and maintain local, central and external relationships in order to influence the regulatory environment, particularly those within France.
You may also be required to supervise other regulatory affairs individuals depending on business need.
You will have at least 5 years experience in a broad range of Regulatory Affairs issues gained within the CRO or Pharmaceutical industry. Extensive knowledge of French regulatory applications and procedures, especially those related to clinical trials in France, along with proven success in agency influencing and negotiation, would be an advantage. |
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| Regulatory Affairs Executive - Brussels |
We are also looking for additional Regulatory Affairs Professionals to join our central strategic team in Cambridge due to our continuing growth. You will be responsible for providing regulatory strategy advice to internal and external clients and will provide project specific regulatory services and co-ordination of various projects which may vary in size and be on a National, pan-European or global basis.
Key aspects of your role will be to prepare regulatory submissions in Europe, South Africa and Pacific Rim, to assist in business development and pricing of projects for Regulatory Affairs in the company and to provide regulatory advisory and training services for regulatory affairs in the company.
You will have experience in a broad range of Regulatory Affairs issues ideally gained within the CRO or Pharmaceutical industry. |
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| GCL - Project Manager |
This position is accountable for project success and performance ensuring timelines, specifications (quality, TAT, etc) and budgets are met with high client satisfaction and service provided along the process. The Project Manager performs the database study setup, supervises all other setup activities, monitors the conduction phase and performs the study closure. The Project Manager assesses feasibility for requests for proposals (RFP’s), analyzing requests and providing recommendations for bids. Serves as the principal contact to the sponsor operational personnel (Clinical team, Study Monitors, other sponsor and CRO staff), and coordinates all project related activities internally and with external vendors.
The Project Manager monitors and manages all aspects of designated clinical trial protocols and is accountable for meeting agreed timelines, budgets, and specifications for deliverables, quality, SLA and TAT. The Project Manager reports and tracks key performance indicators and project variances to clients and internal departments and drives the implementation of according solutions, proactively and professionally handling queries & day-to-day requests to meet client expectations.
This position is accountable for overall project performance and client’s satisfaction by meeting their needs and expectations through the life cycle of the assigned clinical trials.
60% overnight travel required
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| GCL - Data Management Specialist |
Data Specialists may be responsible for any of the following duties: transfer of laboratory data and patient demography to our sponsors and CROs in the specific format(s) requested by the recipient(s); review of data for completeness and quality prior to each transfer of data; programming and validation of result and composite reports to sponsors.
In addition Data Management Specialists may serve as a point-of-contact for particular projects or sponsors and may have additional leadership responsibilities, including review of other employees’ work. Additionally, Data Management Specialists are expected to have expanded knowledge of the processes and procedures involved with data transfers or data setup and the internal data management system and to apply this knowledge in order to provide recommendations for addressing sponsor requests and data management issues.
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| Clinical Research Associate/Senior Clinical Research Associate |
You will be primarily tasked to set up and monitor clinical trials conducted in Belgium as part of international projects. You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service.
With a life sciences degree or nursing
qualification and at least one year's experience of Phase II to IV
trials, you will have in depth knowledge of FDA and ICH GCP
requirements.
SCRAs will have a minimum of two year's experience, including experience of start up, monitoring and close out. As a SCRA you will have the opportunity to mentor more junior CRAs and may be asked to take on project co-ordination activities as a lead CRA.
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| Associate Director - Global Central Labs |
To manage the fiscal, administrative, personnel and operational functions of a
high volume clinical laboratory serving the pharmaceutical industry. Facilitate
maximum accuracy, cost efficiency and productivity and assist with planning and
development. You will be responsible for the functional and administrative of
support staff. To be considered for this role you will have a B.S. in medical
technology and 3 to 5 years experience in managing a high through-put clinical
laboratory. A Master's degree in Business, Hospital and Health Administration or
Laboratory Administration from an accredited college or university or an
equivalent combination of education or experience is desired. Considerable (7 –
10 years) experience in health care laboratory supervision and administration is
required. Reasonable knowledge of personnel and fiscal management is
required. Demonstrated job-related experience with and/or commitment to diversity in
the work/academic environment is required. Excellent written and verbal
communication skills are required. Certification with ASCP or NCA is desirable.
Please send your CV with covering letter to tracey.burch@wilm.ppdi.com |
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