Publication Manager

Functional Area:

• Medical Writing

Duties and responsibilities:

• In collaboration with a multi-disciplinary team of experts, actively drive the development of plans and delivery of clinical, epidemiological and/or health economics scientific publications: peer-reviewed manuscripts and congress plenary activities, i.e., abstracts, posters, oral presentations
• Act as editor for publications by following international standards and ensuring high scientific integrity of data interpretation
• Create and maintain scientific expertise in publications
• Identify appropriate resources for generation of publications, according to priorities

Experience/Skills/Competencies:

• Experience in science, publication or regulatory writing (during PhD, MsC or post-doc experience or within a pharma industry environment)
• Excellent English skills, verbal and written
• Excellent communication skills; diplomacy, cultural sensitivity, strong negotiating skills
• Excellent team worker with good listening skills
• Project Management skills
• Meeting facilitation skills

Education:

• University Degree in life science, biology, chemistry, biochemistry, pharmacology (preferably post-graduate degree or PhD)

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Data Integration Specialist

Functional Area:

• Data Standardisation

Duties and responsibilities:

Tasks include:

• Data standardization and annotation of Case Report Forms
• Developing and/or maintaining database mapping specifications to produce SDTM datasets from source datasets
• Coordinating the development of programs to perform the conversion outlined by these specifications

1 – Technical                                                                             

• Analyze the content and structure of source data
• Analyze the clinical trial protocol
• Creation of data definition files and annotations of Case Report Forms
• Creating and maintaining the database mapping specifications including controlled terminology
• Quality Control of all project deliverables
• Proactively identify and track issues and coordinate the resolution

2 – Non technical

• Understand the scope and timeframe for completion of the assigned tasks
• Participate and contribute in project / team meetings
• Responsible for project status report and project related documentation
• Understand and follow BDLS SOPs
• Improve processes where needed

Experience/Skills/Competencies:

• Good English written and oral communication skills
• Quick learner
• Excellent team player
• Highly motivated and creative
• Able to plan work to meet deadlines and work under pressure
• Excellent organization and interpersonal skills
• Strong understanding of data management and database administration: clinical protocol assessment, Case Report Form design, understanding of clinical data management systems, study start up (database administration, edit check creation/validation) and data base lock
• CDISC SDTM exposure
• Basic SAS knowledge
• Ability to effectively manage time, prepare for meetings and prioritize project work
• Good organisation skills

Education:

• BSc and MSc or equivalent

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eClinical Systems Expert

Functional Area:

• Data Management

eClinical Systems Services include:

• Electronic data capture (eDC) systems
• Clinical trial data captured within eDC systems
• Integration systems between eClinical Systems (eDC, electronic patient reported outcomes (ePROs), safety data management system, electronic health record systems (EHRs), IV/WRS, CTMS, Laboratory Data Management Systems, etc.)
• Clinical trial data integrated between eClinical Systems

Duties and responsibilities:

Clinical Development Project Responsibilities may include:

• Taking an active role on assigned Clinical Development Projects through overseeing and taking Sponsor accountability for the External Parties eClinical Services with respect to scientific/technical content, quality, budget and timing
  
  
• Taking an active role and Sponsor accountability in the screening, evaluation and selection of External Parties delivering eClinical Services for the Clinical Trials
  
  
• Review and approval of budget proposals and contracts of External eClinical Systems Partners for eClinical Services of clinical trials
  
  
• Interacting effectively with the representatives of the  functional areas (Development Project Leaders, Operational Leaders, ICT Project Leaders, Medical Leaders, Safety Officers, CTLs, Biostatisticians, Data Managers, Medical Writers, Quality Monitoring personnel, Regulatory personnel, etc.) to ensure the  eClinical Systems processes and deliveries are fully integrated with the needs of the distinct  functional areas
  
  
• Playing an active role in generic training and support/assistance of External eClinical Systems Parties in the use of specific controlled procedures, generic process flows, timelines and established specifications for eClinical deliverables
  
  
• Participating in yearly review of the External eClinical Systems Parties controlled procedures, process flows, documents and deliverables for consistency with controlled procedures (where applicable) and adherence to Regulatory requirements
  
  
• Attending or participating in meetings as appropriate
  
  
• Participating in the strategic allocation/outsourcing of eClinical Services to External Parties
  
  
• Participating in the strategic selection process of new External eClinical Sytems Parties, as well as evaluation of the quality of their work
  
  
• Taking an active role in overseeing the planning for the eClinical Services in view of submissions for all of the
  
  
• Taking an active role in design of generic documents and specifications, in particular pertaining to the generation of regulatory submission data standards (e.g. SDTM mapping in close collaboration with  Statistics and Medical, …)
  
  
• Close follow-up of the External eClinical Systems Parties resourcing capabilities
  
  
• Participating actively in the creation, review and implementation of new SOPs, Work Instructions, guidelines, processes, documents and other tools to ensure efficient and compliant eClinical Services delivered by the External eClinical Systems Parties

Experience/Skills/Competencies:

• Outstanding written and oral communication skills
• Excellent organizational skills and demonstrated ability to manage projects
• Experience in effectively prioritizing and managing multiple tasks simultaneously
• Excellent interpersonal skills
• Effective problem solving & negotiation skills
• Highly motivated and creative
• Excellent team player
• Able to plan work to meet deadlines and work under pressure
• Accurate, conscientious and thorough
• With preference 5 years of experience in Clinical Drug Development within the Pharmaceutical Industry or related Industry; or with proven professional track record.
• Medical domain: infectious diseases
• In depth understanding of current clinical drug development processes and regulatory requirements
• Knowledge of applicable international guidelines regarding eClinical Systems for clinical trials
• Excellent knowledge of English, both spoken and written
• Knowledge of eClinical Systems (eDC, ePRO, Electronic Health Records, etc.)
• Knowledge of technology platforms for data exchange and integration
• Knowledge of Clinical Data Management Systems (CDMS)

Education:

University degree – medical, paramedical (pharmacy, biology, veterinary, etc.), technical (engineering, …) or equivalent by relevant work experience.

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Clinical Savety Associate

Functional Area:

• Handling of safety cases

Duties and responsibilities:                                                                                           

Tasks may include:

• Triaging, collecting, monitoring, processing, and distributing adverse event reports (serious and non-serious Adverse Event(s) to the sponsor or regulatory authorities and project team within the specified timelines
• Duplication check and book-in of cases, acknowledge receipt
• Code adverse events using the standardized MedDRA dictionary 
• Identification of missing information
• Perform data entry functions required for the safety database
• Provide coverage for serious adverse events reported during non business hours, weekends, and holidays on rotational basis, as required by assigned protocols
• Perform comparative review and reconcile serious adverse events between the Clinical and Safety databases
• Interact with physicians for clarification or missing elements
• Create case files and submit to physician for review
• Aid the project team in the preparation of customized and other regulatory safety reports (i.e. CIOMS, EMEA, BHA, DSMB and Annual Reports)
• Perform other safety-related tasks as necessary

Experience/Skills/Competencies:

• By preference minimum 6 months to 2 years of (relevant) experience
• Good knowledge of pharmacovigilance  process, systems and guidance
• Good knowledge of English (written and spoken)
• Good organization skills

Education:

• Scientific Degree (Bachelor) or equivalent experience
• Bachelor of Nursing , Bachelors Degree with a concentration in the Health Sciences or relevant health care/research experience

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Safety Physician

Functional Area:

• Clinical Safety

Duties and responsibilities:

• Evaluate and analyse reported adverse events
• Write clinical safety reports
• Analyse and evaluate clinical safety for marketed products (in cooperation with other departments) to fulfill the worldwide regulatory requirements
• Assist in, or perform medical analysis and assessment of safety questions and provide advice on safety related medical questions
• Provide medical input to the evaluation of safety signals
• Review clinical protocols to ensure that they are aligned with the Safety sections of the Clinical Development Plan
• Review study reports, investigator brochures and submission applications
• Contribute to pre-PSUR meetings and to the medical assessment of PSURs, review of the final draft
• Coordinate the conception, writing and follow-up of Risk Management Plans
• Provide a proactive reflection on the impact of recommendations or analysis results

Experience/Skills/Competencies:

• Experience in a clinical research and/or pharmacovigilance setting of at least 2 years
• Knowledge or specialized training in pharmacovigilance and signal detection tools (data mining) is an asset, an experience in science / medical writing is a plus
• Good communication skills, ability to manage a wide variety of contacts internal and external
• Strong administrative skills
• Proven analytical and problem solving skills
• Strong interest for legal and safety issues
• Excellent mastery of English, written and spoken
• Integrity and a strong feeling for ethics,
• Self motivating, and able to demonstrate capability to work independently
• Team player, strong sense of urgency, performance driven and delivers to timelines
• Computer literate, familiar with using scientific and clinical data bases
• Very good command of written and spoken English

Education:

• Medical degree : ideally with specialization - neurology, infectious diseases, immunology, medical analysis, internist

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Savety Scientist

Functional Area:

• Safety

Duties and responsibilities:

• (Independently) reviews aggregated adverse event reports for signal detection and management purposes
• Is responsible for the scheduling and creation of the Periodic Safety Update Reports for regulatory agencies (PSURs)
• Assists in the creation/responsible for the creation of the Risk Management Plans (RMPs), in collaboration with the clinical, regulatory and epidemiology departments
• Coordinates (with/without guidance) responses to regulatory enquiries on safety matters Summarizes large, complex data sets, and writes the non-medical sections of the PSURs, US Periodic Reports, RMPs and responses to regulatory enquiries on safety matters
• Responds (with/without guidance) to internal and external non-regulatory enquiries on safety related matters
• Writes Annual Safety Reports and PSRIs for investigational product
• Consideration of safety issues impacting protocols and projects by regular interactions with clinical, regulatory, and project planning personnel
• Assists in the review of/review protocols, study reports, IDMC charters,  and operational activities associated with appropriate data provision and presentation of material
• Follows the regulatory requirements for safety reports such as PSURs and RMPs and is involved in translation of new regulations into the appropriate process
• Represent at meetings with MHRA

Experience/Skills/Competencies:

• Experience in a research laboratory (e.g., as PhD student,), clinical research and/or pharmacovigilance setting of at least 2 years
• Knowledge of regulatory or GCP and/or pharmacovigilance procedures/systems/guidance
• Basic knowledge of pharmaco-epidemiology principles is not required but may be an asset

Education:

• Scientific university degree (e.g., pharmacist, veterinary MD), or university degree completed by broad knowledge of scientific disciplines (virology / immunology / biology and experience in scientific writing or working in a regulatory or clinical development environment

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Pharmaco-epidemologist

Functional Area:

• Support quantitative analysis of post-marketing surveillance data to assess the safety of products; application of sound epidemiological principles to safety signal evaluation

Duties and responsibilities:

May include:

• Study design, database selection, literature review, data analysis, interpretation and reporting
• Evaluate incidence rate of cases of specific adverse events compared to the expected incidence rate estimated from background incidence rates, adjusting for the main confounding factors
• Adequate background incidence rates should be identified from literature search or by using existing databases
• Support Pharmacovigilance in the detection, assessment, understanding, and prevention of adverse effects, particularly long term and short term side effects of drugs and assurance of acceptable healthcare outcomes as prescribed by the objectives of specified pharmaceutical use and therapy
• Collect, monitor, research, assess, and evaluate information from healthcare providers and patients on the outcomes and adverse effects associated with pharmaceutical use
• Perform post-marketing pharmacovigilance studies and analysis using data mining and investigation of case reports to identify and validate relationships between drugs and adverse reactions or anticipated outcomes
• Assess benefits, risk, harm, effectiveness, and efficacy as relates to pharmaceutical usage
• Support drug class reviews and drug usage analyses
• Draft research into a format ready for submitting to peer-reviewed journals
• Perform outcomes, epidemiological, retrospective, and prospective observational epidemiological studies, and adverse drug event analysis using SAS, SQL script, and visual programming tools to extract data from a large database
• Responsible for study design, analysis and interpretation
• Develop methods and analyze cohorts based on dose-effect, de-challenge, re-challenge data, masking, of events and channeling
• Design analytic studies to measure relative risk between two medications, evaluate and test several techniques to address issues of potential confounding (e.g., stratification, patient matching, logistic regression) and determine which method or methods should be used in future studies

Experience/Skills/Competencies:

• SAS programming is an asset
• Effective communication
• Demonstrates comfortable level of oral and written English
• At least 2 years experience in (pharmaco-)epidemiology or related activities

Education:

• University degree, Ph.D. or MD level Pharmacoepidemiologist
• Masters level acceptable
• Five years Ph.D./MD level experience preferred

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Laboratory Coordinator

Functional Area:

• Project Management / External laboratory coordination

Duties and responsibilities:

1 – Technical

• Perform clinical laboratory activities in the scope of GCRD. Define and ensure standard processes across projects in collaboration with other departments such as R&D, Procurement, QA, external parties
• Proactively define and analyze KPls and collect feedback from all stakeholders to identify trends in performance/operational issues
• Pro-actively solve issues, escalate issues to (upper) management when appropriate
• In own field of expertise, participate in/ prepare audits with QA R&D to ensure that external Lab meet appropriate safety and regulatory standards; Ensure link between Clinical Project teams and QA R&D to establish external laboratories audit program with focus on project needs
• Ensure QA R&D audit report is provided to the relevant people within the clinical project team
• Actively participate and provide input into budget and workload forecast (for internal and external partners), ensure follow-up of budget and invoicing, highlight any deviation from initially agreed budget and/or contract collaboration with Clinical Procurement, planning manager, Clinical development manager and Clinical finance

2 – Non technical

• Act as contact between the company and the external laboratories
• Act transversally, between the different stakeholders including CPM, QA, external...with focus on external laboratory deliverables to coordinate the activities
• Establish network of communication and build external collaborations to facilitate smooth partnerships
• Identify the necessary processes and quality assurance procedures to ensure that external laboratories meet the company standards including SOP/GCP-lCH/ GLP requirements and project requirements

Experience/Skills/Competencies:

• BSc or equivalent background

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