Clinical Development Associate Manager, CDAM to AstraZeneca

We are now looking for 1 to 2 Clinical Development Associate Managers, CDAM, for exciting long term assignments at AstraZeneca in Gothenburg. With the right profile and a lot of passion, this might be the start of a fruitful employment at Pema Engineering & Science.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena

Clinical Operations delivers global clinical trials from late stage projects using internal expertise in excellent program and study management, coupled with that of external partners. The unit is industry leading in the management of large outcome studies. They design, run and deliver high quality and patient centric clinical trials from all of AstraZeneca´s therapy areas.

The role

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.

Accountabilities/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
• 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

 

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
• 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
• Good understanding of clinical data flow
• The ability to develop advanced computer skills to increase efficiency in day to day tasks
• Excellent verbal and written communication and presentation skills
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines
• Willingness to travel both domestically and internationally
• Demonstrates sound knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes
• Proactively identifies risks and issues and possible solutions
• Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships
• 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, plan, coordinate, and facilitate meetings
• Displays excellent organization and time management skills
• Demonstrated Project Management skills

 

Are you the perfect match?

If you have any questions regarding the assignment, please contact Business Area Manager, Karin Lyckemalm at karin.lyckemalm@pemapeople.se or 0720-808934

You apply by register below and attach CV and cover letter.

Last applicxation day is 2016-09-25, however selection is done continuously.

We are looking forward to receiving your application!

 

Pema People AB is staffing and recruitment Company that has been active since 1997. Pema People AB is a company in constant development and since 2016 we are present in Gohenburg. We match the best people to interesting companies and assignments. We offer our employees maximum experience in short time.