emploi attaché de recherche clinique

4Emplois trouvés

4 emplois trouvés pour emploi attaché de recherche clinique

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(Senior) Clinical Research Associate - Client-dedicated, Vaccines

CBRE

Brussels, BE
Il y a 30+ jours
Brussels, BE
Il y a 30+ jours
Description

PPDis a leading global contract research organization providing comprehensive,integrated drug development, laboratory and lifecycle management services. Ourclients and partners include pharmaceutical, biotechnology, medical device,academic and government organizations. With offices in 48 countries and morethan 21,000 professionals worldwide, PPD applies innovative technologies,therapeutic expertise and a firm commitment to quality to help clients andpartners bend the cost and time curve of drug development and optimize value indelivering life-changing therapies to improve health.



We have an excitingopportunity for a Clinical Research Associate to join the team in Madrid and bededicated toone clientonly. You will beworking exclusively on projects for this one client, utilizing their systemsand SOPs, monitoring their sites.



This is a greatopportunity for CRAs with minimum2 years CRA experienceworking within the life science sector for pharmaceuticalcompanies, Biotech companies or CROs, who would enjoy the opportunity to workfor a CRO, with great opportunities for futurecareer progression. Experience withOncologyorVaccines studies is also necessary.



Responsibilities:


  • You should thrive in project teams and be focused on delivering exemplary levels of customer service.
  • You will perform and coordinate all aspects of the clinical monitoring process.

Qualifications

Education andExperience:

  • Degree inpharmacy, life science or related field
  • Experience in a pharmaceutical, biotech or CRO company
  • Independentclinical monitoring experience


Knowledge, Skills andAbilities:

  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Management of regulatory and / or IEC questions
  • Development and preparation of the local informed consent form
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Management of the delivery of study supplies
  • Strong customer focus
  • Effective interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Ability to work in a team or independently as required
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English, Dutch and French language and grammar skills
  • Good presentation skills


PPD Offers:


As an equal opportunityemployer, PPD believes that employees are the key to its success and iscommitted to your professional growth. We offer anattractive salary,comprehensive benefits packageas well aspersonaldevelopment andtrainingprograms. We offer you apositive and supportive working environmentwithin one of the most engaged teams in the industry, recognizedas the cornerstone of our success.



*LI-MP1

PPDBE-BE-Brussels-Brussels BE St Stevens Woluwefalse749756truefalse
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Associate Director, Medical Affairs Oncology (Breast Cancer, Solid Tumours)

Gilead Sciences, Inc.

Brussels
Il y a 30+ jours
Brussels
Il y a 30+ jours
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.
Job Description
We have an exciting opportunity within the Medical Affairs function to lead our initial efforts to advance our breast cancer expertise, the role will actively participate in a cross-functional team dedicated to strengthening our role in Immuno-Oncology.
The Associate Director, Medical Affairs will focus on executing the medical strategy in Belgium-Luxembourg. This role requires very close collaboration with national and international colleagues from within Medical Affairs and the extended cross-functional team. The role is office-based in Brussels and requires national and international travel (including internal meetings and external scientific conferences) once travel restrictions are eased. The position will report to the Senior Medical Director Belux.
Specific responsibilities:
+ Executes Medical Affairs activities and scientific projects based on the medical strategy and Plan of Action, in close collaboration with the cross-functional oncology team. Will be involved in the planning and development of the local Medical Affairs plan in the Therapeutic Area.
+ Works with the cross-functional brand and launch team.
+ Develops and conducts medical education and communication activities, including digital, face-to-face, and print.
+ Is involved in scientific publication activities.
+ Is a company representative to groups of experts, medical professional groups, societies, patient representatives, regulatory groups, and represents the company at national and international scientific meetings.
+ Establishes and maintains strong working relationships with external medical experts locally and internationally, including academic societies.
+ Plans and conducts Advisory Boards as needed to obtain insights.
+ Presents scientific and clinical data in a variety of different settings.
+ Works collaboratively with Gilead personnel in European affiliates, Global Medical Affairs, Clinical Research, Marketing, Market Access, Sales, Regulatory Affairs, Drug Safety, Public and Government Affairs.
+ Supports the generation of scientific data through collaboration with the Gilead personnel in R&D and Clinical Operations, site support in clinical trials, and by developing local clinical trials including study protocols, as needed.
+ Is involved in supporting and coordinating Investigator Sponsored Trials - including collaboration with investigators and internal Gilead personnel.
Requirements:
+ Advanced scientific degree (i.e. MD, PharmD, PhD)
+ Excellent clinical and scientific understanding of oncology, preferably solid tumours, including breast cancer
+ Experience in a relevant medical/scientific role, preferably in the pharmaceutical industry and with product launch experience
+ Ability to embrace Gilead’s leadership commitments and patient-centric values, including highest ethical and compliance standards
+ Strategic mindset with a focus on collaboration and excellence
+ Excellent written and verbal communication skills are required in Dutch, French and English, along with the ability to understand, analyze and communicate medical concepts in a clear and concise way.
+ Strong interpersonal and relationship building skills
+ Ability to successfully navigate fast and dynamic situations where there is ambiguity, uncertainty, and change
+ Excellent organizational skills including attention to detail and prioritization
+ Ability to work in a cross-functional matrix
+ Preferably experience of working in an international environment
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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Project Manager - Central Labs

CBRE

Zaventem, BE
Il y a 30+ jours
Zaventem, BE
Il y a 30+ jours
Description
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.
As a Project Manager you will manage all aspects of study programs, while collaborating with diverse teams.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
Monitors and manages all aspects of designated clinical trial protocols in Global Central Labs and 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. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major sponsors and is responsible for large study programs. Prepares and maintains process documents and acts as a back-up for the (Associate) Director PM, when needed. Mentors Project Managers.
Essential Functions:
  • Provides oversight and coordination of study initiation. Reviews, interprets, translates and programs study protocols into a complete and accurate database. Communicates with internal departments and external vendors and ensure the project requirements are understood, agreed and followed at all times. Facilitates the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel). Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
  • Prepares the study specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated study master file with version controls for specs, budgets and contracts. Ensures sponsors have authorized and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assures compliance with FDA and Good Clinical Practice guidelines, PPD SOP’s, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.
  • During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Obtains other functions’ commitment to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, manages and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries
  • Actively consults with IT and data management development groups in the design, validation and implementation of new software and functionalities pertinent to project management activities.
  • Consults with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments. Advises on possible solutions if needed. Drafts responses for proposals.
  • Guides and supports work flow of Projects Managers and Set-up Administrators with special attention to training junior personnel. Performs as a mentor and trainer for (newly assigned) Project Managers, identifies areas for development and efficiencies in performing tasks. Authors, reviews, revises and implements relevant procedural documents. Serves as a back-up for the (Associate) Director PM, when needed.

Qualifications Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
  • Strong verbal, written and presentation skills
  • Superior time management, planning, and organizational skills
  • Competent with specific computers and enterprise applications, including office productivity
  • Ability to program the IT system according to protocol requirements
  • Proven analytical skills
  • Demonstrated compliance with procedures and policies
  • Ability to perform multiple tasks effectively in a stressful environment
  • Extensive knowledge and experience in Project Management in Global Central Lab environment
  • Strong client relationship management skills
  • Ability to work effectively with multi-level teams

PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you
PPDBE-BE-Zaventem-Zaventem BE Cluster Pkfalse801086truefalse
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Remote Site Monitor (Level I) - Belgium

CBRE

Brussels, BE
Il y a 14 jours
Brussels, BE
Il y a 14 jours
Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.


Currently, we are looking for a Remote Site Monitor in Belgium.
As a Remote Site Monitor, you will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents by reviewing study data from various sources remotely. You will contact study sites to collect study documentation, resolve issues and request outstanding information.
About the role:
Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOPs. Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable. May contact the study sites to collect study documentation, resolves issues and requests outstanding information if applicable. Detailed tasks and responsibilities assigned to RSM-Central or RSM-Local positions are outlined in the task matrix.
Essential Functions:


  • According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities detailed on the task matrix, including but not limited to the following:
  • Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
  • Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines. Raises manual queries in EDC when applicable.
  • Remotely reviews study logs as deemed necessary.
  • Conducts and documents site management calls/contacts according to the monitoring plan. Participates in investigator meetings. Investigates and follows-up on centralized monitoring findings.
  • Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study on a regular basis. Conducts remote investigations into site performance using a risk based monitoring approach: applying root cause analysis (RCA), critical thinking and problem-solving skills to help identify site process failure and work on corrective/preventive actions to bring the site into compliance and decrease risk.
  • Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, etc.
  • Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
  • Provides trial status tracking and progress update reports to study manager.
  • Participates in the investigator payment process, if applicable.
  • Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc.
  • Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses.
  • Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines.

Qualifications

Education and Experience:


  • Bachelor’s Degree in a life science-related field OR Registered Nurse license along with an Associate’s Degree in Nursing.
  • Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.
  • In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
  • Prefer individuals who aspire to advance into a CRA role.


Knowledge, Skills and Abilities:

  • Basic medical/therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and PPD procedural documents
  • Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
  • Ability to successfully complete the RSM Onboarding Workshop
  • Ability to evaluate medical research data
  • Ability to advise, counsel, and motivate investigational sites
  • Effective oral and written communication skills with the ability to communicate effectively with medical personnel
  • Excellent interpersonal and customer service skills
  • Good organizational and time management skills
  • Proven flexibility and adaptability
  • Strong attention to detail
  • Ability to work in a team or independently, as required
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
  • Ability to coach and mentor site personnel.
  • Good computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable.
  • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
  • Excellent English language and grammar skills


What we offer



At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.



As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.




PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD –


If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.



#LI-SG1


BE BUBE-BE-Brussels-Brussels BE St Stevens Woluwefalse828682truefalse

Plus de résultats à afficher

Date de publication

Il y a 30+ jours

Description

Description

PPDis a leading global contract research organization providing comprehensive,integrated drug development, laboratory and lifecycle management services. Ourclients and partners include pharmaceutical, biotechnology, medical device,academic and government organizations. With offices in 48 countries and morethan 21,000 professionals worldwide, PPD applies innovative technologies,therapeutic expertise and a firm commitment to quality to help clients andpartners bend the cost and time curve of drug development and optimize value indelivering life-changing therapies to improve health.



We have an excitingopportunity for a Clinical Research Associate to join the team in Madrid and bededicated toone clientonly. You will beworking exclusively on projects for this one client, utilizing their systemsand SOPs, monitoring their sites.



This is a greatopportunity for CRAs with minimum2 years CRA experienceworking within the life science sector for pharmaceuticalcompanies, Biotech companies or CROs, who would enjoy the opportunity to workfor a CRO, with great opportunities for futurecareer progression. Experience withOncologyorVaccines studies is also necessary.



Responsibilities:


  • You should thrive in project teams and be focused on delivering exemplary levels of customer service.
  • You will perform and coordinate all aspects of the clinical monitoring process.

Qualifications

Education andExperience:

  • Degree inpharmacy, life science or related field
  • Experience in a pharmaceutical, biotech or CRO company
  • Independentclinical monitoring experience


Knowledge, Skills andAbilities:

  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Management of regulatory and / or IEC questions
  • Development and preparation of the local informed consent form
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Management of the delivery of study supplies
  • Strong customer focus
  • Effective interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Ability to work in a team or independently as required
  • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English, Dutch and French language and grammar skills
  • Good presentation skills


PPD Offers:


As an equal opportunityemployer, PPD believes that employees are the key to its success and iscommitted to your professional growth. We offer anattractive salary,comprehensive benefits packageas well aspersonaldevelopment andtrainingprograms. We offer you apositive and supportive working environmentwithin one of the most engaged teams in the industry, recognizedas the cornerstone of our success.



*LI-MP1

PPDBE-BE-Brussels-Brussels BE St Stevens Woluwefalse749756truefalse
Source: CBRE