Patient Reported Outcomes Scientist

AstraZeneca - Gaithersburg, MD4.1

Full-time
EducationSkillsBenefits
Patient Reported Outcomes Scientist Job Description

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Patient Reported Outcomes Scientist, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

The Patient Reported Outcomes Scientist will work closely with PRO directors and study teams to implement PRO and other COAs into clinical trials to ensure high quality evidence supporting products’ regulatory approval, reimbursement and commercialization.

The incumbent will be driving efficient implementation of PRO into studies:

To translate the PRO strategy into a fully implemented program
Leads PRO function interactions with internal and external teams to apply strategy at the study level and oversee PRO implementation
Responsible for the scientific aspects of the eCOA implementation
Supports the PRO strategy development
Support development of relevant PRO training materials for patients, investigators and monitors
Ensure appropriate standards are applied and participate in development of new standards
The incumbent will interact internally with teams (e.g. study teams, CPT, IPT where appropriate) and externally with PRO strategic partners, linguistic validation and eCOA providers. with regulatory authorities and key external experts, as well as with relevant AZ cross-functional teams (e.g., GPTs, CPTs, GMTs, Payer Teams).

Accountabilities/Responsibilities

Drive the everyday work of PRO implementation in studies
Support PRO director in development of PRO strategy
Draft CSP text based on a pre-defined PRO strategy
Draft PRO SAP text
Provide support to manage the relationship with vendors and oversee their deliverables (PRO strategy, linguistic validation, interview studies etc)
Provide scientific expertise of ePRO implementation
Support the development and implementation of the PRO training strategy - monitors, investigators, patients
Perform Blinded Data Reviews
Assist with review of results and the preparation of regulatory documents
Minimum Requirements –Education and Experience

Bachelor’s Degree in Life Sciences, Information Technology or Business/Finance
Familiarity with clinical research from industry or CRO work experience
Experience with PRO development or usage in clinical studies is preferred but not required
Skills and Capabilities

Able to implement projects including interactions with stakeholders
Good written and verbal communication skills, collaboration and interpersonal skills
Ability to define clear scope of project and provide support.
Ability to look for and champion more efficient and effective methods/processes
Integrity and high ethical standards
Next Steps – Apply today!

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, gender or gender 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.