15 days old

Clinical Research Laboratory Senior Technician

Pfizer
Anderlecht, Brussel 1070
Our Pfizer Clinical Research Unit (PCRU) in Brussels (Anderlecht) is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies).



**JOB SUMMARY**

The Clinical Research Laboratory Senior Technician's main responsibility includes proper sample management, storage and shipment on a day-to-day level.



+ Involved in different various activities in the laboratory but also in data collection.

+ Perform the schedule of the laboratory for day-to-day activities

+ Training of new colleagues and updating the training materials

+ Inventory management and controls for the laboratory

+ Optimize Operational Control and Effectiveness

+ Assures close partnership with Clinical Project Managers and Principal Investigator to assure successful study delivery and high quality data

+ Fosters positive community attitudes and volunteer trust through professional behavior and ongoing communication.

+ Ensures the role of Laboratory Shift Leader like a member of the laboratory staff having a good overview of the Lab & unit operational activity, and solely responsible for coverage during shift.



**JOB RESPONSIBILITIES**



The Clinical Research Laboratory Senior Technician is responsible for the day-to-day Laboratory work.

Laboratory



+ Ensure the control of the laboratory environment, safety specification, the maintenance and calibration of laboratory material required to conduct clinical trials.

+ Responsible for orders of the laboratory (identification of supplier, making contact, order tracking, ...)

+ Must be able to follow written and oral instructions and comply with safety and laboratory procedures.

+ Creation/review and update SOP's of the laboratory when it is necessary

+ Analyze samples and report results as according to the analytical Lab processes



Laboratory Shift Leader



+ To attend to the Shift Report on the clinical floor in the morning and/or evening.

+ To be sure that all samples are ready before the beginning of the activities. The overall responsibility will be maintained until hand over to next shift.

+ Keeps daily Laboratory organization flowing smoothly following the organization (staff allocation and study schedules) planned by the scheduling team. In case of issues, Laboratory Shift Leader makes arrangements to reorganize the workload in order to ensure correct study/Laboratory conduct with respect to GLP and personnel qualifications: Re-distribute personnel, tasks and reorganizes activities on an efficient manner.

+ Responsible of coordinating Lab colleagues activities during the same shift & anticipate the activity for subsequent shift delegating appropriately the remaining tasks.

+ To be the gateways between the start-up and the operational teams. To have a global vision of studies and be aware of the different specificities and to anticipate the work preparation and delegates appropriately between Lab colleagues.



Sample Management



+ Responsible to ensure quality throughout sample processes and beyond

+ Manage all necessary preparations in regard to the laboratory for adequate execution of a protocol in a timely manner

+ Ensure proper lab samples handling (documents for staff use: trolley sheet, centrifugation sheet, urine collection sheet, order Lab supplies, etc...)

+ Identify new lab equipment if necessary

+ Support new lab technique (biomarkers, material, etc...)

+ Assisting in the validation of methods when it is necessary.

+ Support setting up of EDCMS as appropriate



Shipment



+ Responsible for PCRU samples shipments (packing, documentation, organization with sender).



Other



+ Others duties/tasks will include but are not limited to:



+ Record and update adverse events, intervene as appropriate

+ Provide ongoing and accurate information and support Volunteers/Patients regarding clinical trials to facilitate subject compliance

+ Particiate and ensure correct actions to ensure laboratory quality

+ Monitor and document study subject compliance

+ Maintain accuracy, accessibility, and confidentiality in volunteer/patient records

+ Record and communicate or resolve any discrepancy to study protocols in regards to laboratory

+ Facilitate positive attitude and trust by the volunteer/patient population toward participation in clinical research

+ Ensure development of new procedures required by the protocol as "superuser" and train staff accordingly



Training



+ Participate in training courses as appropriate

+ Organize and assist in the training of PCRU staff and contractors with less experience and expertise

+ May Ensure Lab training requirements are fully achieved for protocol execution and for all protocol related procedures

+ Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation



**QUALIFICATIONS / SKILLS**

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.



+ Minimum of a Diploma/ **Bachelor degree Medical Biology** or equivalently

+ Superior written and verbal skills are essential; including the ability to communicate complicated research principles in easily understandable language.

+ Must be **available for various shifts** (weekends/evenings/nights/public holiday)

+ **English** language skills is highly recommended, your second language would be **French or Dutch**

+ Excellent communication skills **Minimum of 3 years of Laboratory experience**

+ Successful study conduct of all Clinical Research Unit studies in accordance with ethical, legal, and moral standards, Good Clinical Practices (GCPs) and Good Clinical Laboratory Practices (GCLPs), WRD management requests and drug development goals.

+ Working knowledge of computers and ability to adapt rapidly and easily to clinical research data systems and associated issues/risks

+ Ability to function as an effective team member in diverse workgroups to accomplish business objectives

+ Demonstrates effective communication with management group and internal/external customers

+ Group members are able to perform and collaborate in teams to problem solve for increased team productivity

+ Must be proactive, showing initiative and positive team spirit

+ Accountability

+ Demonstrate ability and flexibility to work alternative or additional hours internally and externally (weekends/evenings/nights/public holiday) to provide study activity coverage



**ORGANIZATIONAL RELATIONSHIPS**



+ Report to the Laboratory Team Leader

+ Matrixed relationship with all PCRUs departments.

+ Matrixed relationship to multiple Pfizer WRD & Development Operations departments



**RESOURCES MANAGED**



+ May determine the necessary Laboratory materials required for study conduct with appropriate colleagues.

+ May determine resources needs and level of competencies in regards to laboratory part of the protocol.



**What we offer**



We offer a permanent contract, competitive salaries and customized benefits packages (hospitalisation insurance, outpatient insurance, meal vouchers, public transport reimbursement) . We offer a supportive and diverse culture and unparalleled career development opportunities.



Working at the Pfizer Clinical Research Unit means that you will participate in the development of drugs that bring real benefit to patients. You will be an actor in the challenges that the world is facing, in full compliance with quality and safety standards. The PCRU is working closely with different departments at Pfizer and exchanges and collaborates with other research units based in the US.



Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story.

Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2) Elsene , the Belgian headquarters, 3) Puurs , Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center.

More information can be found at www.pfizer.com , www.pfizer.be and on Facebook and Twitter.



Research and Development

Categories

Posted: 2021-03-29 Expires: 2021-04-28

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Clinical Research Laboratory Senior Technician

Pfizer
Anderlecht, Brussel 1070

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