AstraZeneca Pharmaceuticals LP Clinical Development Associate Manager in Warsaw, Poland
Coordinate operational aspects of AZ and Investigator Sponsored studies from SS/Proposal through CSR/Publication.
Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
Interface with Data Management Center representatives/Data Management Department, to facilitate the delivery of study data
Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives
Implement globally agreed Operations and Clinical Development strategies including processes and use of technical systems related to Operations
Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
Contribute to review of new/amended/unique project Clinical Information Standards (CIS) Standards Repository Components
Lead the preparation of study documents as delegated by Clinical Development Manager ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc)
Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)
Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
Monitor study conduct and progress, proactively identifying to and resolving with the Clinical Development Manager, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary
Contribute to ad hoc team productivity and efficiency by providing direction and facilitating good team dynamics
Provide input into non-drug project work including training activities, and development of procedures as needed
Minimum Requirements –Education and Experience
Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
Experience working on clinical studies, across different phases of drug development
Relevant industry or health care experience
Proven organizational and analytical skills
Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
Excellent knowledge of spoken and written English
Skills and Capabilities
Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas
Good understanding of clinical data flow
Excellent verbal and written communication and presentation skills
Demonstrates ability to work independently, as well as in a team environment
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, 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.