AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Medical Scientist, Study Data Review - Immuno-Oncology
Job Description: Medical Scientist, Study Data Review - Immuno-Oncology
Location: Cambridge, United Kingdom
Salary: We offer a competitive salary and benefits package.
At AstraZeneca we work together across global boundaries to develop effective new medicines for patients.
AstraZeneca is a leader in the development of oncology medicines including immuno-therapies. A meaningful component of our future strategy includes the investigation of the therapeutic potential of immuno-oncology drug combinations in a variety of tumour types. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.
Main Duties and Responsibilities:
You will contribute to projects within oncology to support the successful passage of our medicines through the late phases of the drug development process and collaborate to deliver one or more elements of these projects as a technical expert with an emphasis on clinical data review. You will engage in the review of study protocols and related documents including but not limited to the review of eCRFs, edit checks and completion guidelines included in your study. In your role, you will work closely with a core study team (including the Global Study Leader, Study Physician, Study Statistician and other Medical Scientist colleagues), in the development of a comprehensive study specific process to ensure a well-defined data review and cleaning plan during study setup. You will be an integral part of the team responsible for maintaining compliance with AZ standards and the clinical data review plan. You will liase with and facilitate alignment of data cleaning activities with the site monitoring team. You will be responsible for the development of timelines around these core activities consistent with planned analyses.
During the recruitment and maintenance phases of the clinical trial, you will use specified data review tools to review and query important study data such as study entry criteria, laboratory data, demographic data, concomitant medications, Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Adverse Events leading to Discontinuation (DAEs). You will participate in study team meetings and report on the progress of data review and cleaning activities. You will be responsible for timelines for completion of planned activities and proactively identify challenges or opportunities for modifications to the process. You will also support the study team in the preparation of patient narratives to support regulatory submissions and IDMC meetings. Your input may include the identification of data trends and recommendations for improvement in process, tool deployment or training opportunities You will also have responsibility for the review and presentation of study data which may be used to support regulatory submissions.
You will work closely with the study physician to ensure that the study data is well-prepared and ready for medical review as required.
You will have key relationships with teams within AstraZeneca including but not limited to your assigned study teams, patient safety teams, data management and programming teams. We also have strong relationships externally with contract research organisations, medical science liaisons, and medical monitors. You will coordinate actions and information exchange between these partners to ensure the highest standards of accuracy and completeness of the study data.
Essential Experience and skills:
- Primary degree in a medical profession such as doctor, pharmacist, nurse, nurse practitioner, dentist, with pharmacovigilance background, or equivalent work experience in directly related fields
- Experience working on clinical studies and/or study safety methodology
- Deep understanding of clinical data flow
- Experience handling and interpreting the results of clinical trials, as well as exposure to writing components of clinical study protocols
- Strong organisational and data analytical skills
- The ability to working collaboratively
- Experience of authoring or reviewing scientific documents
- Understanding of the clinical study and drug development process, and GCP/ICH guidelines in relation to study delivery operational activities
- Strong attention-to-detail, and ability to concisely review and summarize large amounts of complex information
- Ability to multi-task in a high-volume environment with changing priorities
- Well-developed interpersonal skills
- Experience leading and managing a team
- Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external organizations.
Desirable Experience and skills:
- Project management of clinical studies or components supporting clinical studies
- Experience using data review tools such as JReview, JMP Clinical, or Spotfire
- Experience in medical writing and/or producing patient narratives
- Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external organizations, on global studies, across different phases of drug development
- Ability to develop and/or apply advanced computer skills to increase efficiency in day to day tasks
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.