Fresh Vacancies at Thermo Fisher Scientific

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

• Acts as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.  
• Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.  
• Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.  
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.  
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.  
• Provides training, guidance, and project leadership to junior team members.  
• Provides general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.  
• Provides input into bidding process as requested.

Qualifications - External

Education and Experience: 

• Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 8 years' experience in hands-on programming, with lead programming experience.
• OR 
• Bachelor's degree in a related discipline and at least 10 years' experience in hands-on programming, with lead programmer experience.

Knowledge, Skills and Abilities: 

• In-depth understanding of one or more programming languages. SAS required.
• ADaM, TLF programming, DMC support and regulatory support experience.
• Proven experience as an independent, lead programmer.
• Experience programming complex analysis datasets and outputs (efficacy, complex lab and regulatory requests)
• eCRT and define.xml knowledge
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language  
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team, training and mentoring others
• Solid project management skills to act as project lead across the most challenging and complex projects.
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

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Key roles and responsibilities of the Clinical Research Physician II include:

• Caring for and protecting the safety of participants through ethical conduct; this should receive the highest priority at all times during all aspects of the study.
• Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the - requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations.
• Ensuring delivery of high quality data and adherence to ALCOA-C principles at all times.
• Playing an active role in site leadership aspects, both on and outside of study conduct.

To be considered for this exciting opportunity you will need the following skills and experience:

• A valid medical degree within the country of practice with at least 2 years working as a licensed physician
• Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work
• Thorough understanding of medical terminology, drug safety, and interpretation of lab reports 
• Have working knowledge of GCP (ICH/GCP and local regulations compliance) and current GCP certification
• Demonstrate the inclination to provide practical help and guidance to colleagues, providing practical solutions for any problems and supporting their development
• Show meticulous attention to detail in recording patient information and data ensuring any queries are acted upon in a timely and efficient manner
• Be a team player, capable of building and sustaining positive relationships with colleagues as well as patients and participants
• Experience in clinical research; principal investigator experience preferable
• Dispensing license preferable