CDAM (Clinical Developer Associate Manager) Study Delivery at AstraZeneca

We are now looking for a Clinical Associate Manager for an assignment at AstraZeneca.

You will 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


Uppdragsgivare: Proffice Life Science



Ort: Göteborg



Deadline for applications: 2014-02-03



More information: Medina Sundström 0733-434153 or Maria Elmberg 0733-434018.



Organization/Business description:
Proffice Life Science is the leading Nordic specialist of temporary recruitment services within the Biotech and Chemtech industries. We are able to provide our Nordic clients with highly skilled and experienced specialists from all over Europe.

All consultants, employed by Proffice, are specialists. Proffice is one of the largest and most well-renowned staffing agencies in Sweden. All consultants, hired by Proffice, have secure and permanent employment contracts with a certified staffing agency. We offer excellent benefits and personal development opportunities within a wide range of positions and industries.

Our clients expect only the best from Proffice and we expect only the best from our consultants. As you will spend your working day on our clients' premises, you will have to not only be an expert in your field, but also a flexible, independent and social member of the team. You thrive on new challenges and welcome new opportunities. If this appeals to you, we offer a stimulating job, with excellent benefits such as private medical insurance, discounted gym membership and further contributions to health care related activities.

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