Clinical Developer Associate Manager

Adecco is the largest recruiting and staffing company in the world. Adecco Life Science is one of our specialized Business Lines, which works exclusively with Staffing Services and Recruitment of personnel for the Life Science industry. Our customers are within the Pharmaceutical-, Biotech- and Medtech companies. We focus on positions within Regulatory Affairs, Medical Affairs, R&D, QA, QC, Clinical Research, Marketing and Sales. We are now recruiting a Clinical Developer Associate Manager, location Mölndal. Preferably the candidate start in February and the assignment will initially continue until the end of the year. The candidate will be employed by Adecco.

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

 What do we offer?

Adecco is the world´s largest recruitment and staffing company and our most important asset is our qualified employees. With us, and on our customer assignments, you, as a consultant, will be appreciated for your difference-making competence! Your bank of experience will grow, as will your social and professional network of contacts. Adecco can offer you the opportunity of interesting assignments at attractive companies, of positions that perhaps never will be put on the open market.

We want you to feel good and will give you subsidies for preventive healthcare and discounts on training cards. In order for you to feel secure, you will also be covered by insurance and corporate healthcare.

Are you interested?

Then you should apply as soon as possible. The position is to be filled immediately, and, for that reason, work with recruitment is being done on a continual basis during the application period.

We look forward to your application!