AstraZeneca: Clinical Developer Associate Manager

Experis Engineering offers specialists and managers through interim consulting, recruitment and project solutions. By combining our industry experience with our knowledge of human potential, we make both individuals and businesses grow and develop. Experis Engineering is present on 30 locations in Sweden and in more than 50 countries worldwide.

For a consultant assignment during 1+ year at AstraZeneca in Mölndal we are now looking for a Clinical Developer Associate Manager (CDAM) within Study Delivery.

Description
Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR). Work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.

Responsibilities
- 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.
- 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
- Lead the preparation of study documents as delegated by Clinical Development Manager
- Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools
- 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
- 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

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
- Computer proficiency
- 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
- Excellent interpersonal skills and proven ability to facilitate team building and team work
- Proactively identifies risks and issues and possible solutions
- Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates ability to learn new therapy areas
- Demonstrates ability to prepare and deliver study related training materials
- Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
- Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
- Demonstrated Project Management skills (e.g. leading delivery team)
- Excellent mentoring skills and ability to develop others