Job Opportunities at Thermo Fisher Scientific

Summarized Purpose:

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products, ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Essential Functions:

• Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

• Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to  client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line ofcommunication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
• Contributes to departmental process improvement initiatives.

Clinical Trial Support:

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

• Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
• Medically reviews adverse event and serious adverse event data from all sources(solicited, spontaneous, literature, etc.) as contracted.

Job Complexity:

• Develops solutions to highly complex and unique issues that impact and address future concepts, products or technologies.

Job Knowledge:

• Having broad expertise or unique knowledge in Pediatrics or Internal Medicine with Infectious Disease and/or Rare Disease experience.

Education and Experience:
MD Or Equivalent Required. Active Medical Licensure Preferred.
Knowledge, Skills and Abilities:

• Therapeutic expertise across one or more medical speciality or sub-specialities
• Strong decision-making, problem solving, organizational skills and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. Medra)
• Flexibility to travel domestically and internationally
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent in spoken and written English
• Excellent interpersonal, influencing and team building skills
• Understanding guidelines (FDA, ICH, EMA and GCP)
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to act as a mentor/trainer to other staff within PV

go to method of application »

• The Data Transformation and Submission(DTS) group within our Biostatistics & Programming department performs active global CDISC submission development for clients in our Biotech, Biopharma and FSP groups. There is also responsibility for Spotfire exploration, SDTM, DSUR reporting, eCRT (Define.xml) as well as cross functional development initiatives with various internal departments, including CDM, Early Dev Services, PVG, etc. The DTS group also works on many stand-alone studies that are led and driven fully within the group.
• As a Principal Programmer within DTS, you will perform specification, development, quality validation and regulatory submission compliance for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables, using Windows SAS Grid. You will deploy Spotfire dashboards, Safety notifications and reporting for Medical Monitor review and regulatory actions. As a DTS team member, you will be a key team player for internal Biostatistics interactions and client engagement on CDISC submission topics, or internal contact for procedural and technical solutions.
• Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight.

Your responsibilities will include (but are not limited to) the following:

• Act as programming lead on Phase II-IV group of studies.
• As programming lead assume leadership responsibility as a contributing member of a global project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
• Provides input into bidding process as requested.
• May provide general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials etc.
• Provides training, guidance, and project leadership to junior team members. - Develop instructional training and education materials for the wider B&P community.
• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF)
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.

To be considered for the role you should have the following qualifications and experience:

• Master's degree in computer science, statistics, biostatistics, mathematics, or related field and at least 4 years of experience that provides the knowledge, skills, and abilities to perform the job requirements,

OR

• Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent formal academic / vocational qualification, and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge/Skills:

• In-depth understanding of one or more programming languages
• Strong attention to detail
• Strong problem solving and innovative skills
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated leadership, initiative, and motivation
• In-depth understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team
• Solid project management skills to act as project lead across the most challenging and complex projects
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.