Klinisk prövningsledare

Clinical Development Associate Manager – CDAM

We are now recruiting a CDAM working as a consultant at AstraZeneca Mölndal. The assignment starts May 2nd until December 31th.

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.

Business: Dfind Science & Engineering

City: Göteborg

Omfattning: Heltid

Deadline for applications: 2016-02-17.

More information: Birgitta Nyström, birgitta.nystrom (at) dfind.se.

Qualification:

• Coordinate operational aspects of AZ late-phase 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

• 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 operational delivery

• Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents

• Provide input to data management documents (e.g. Case Report Form, Data Management Plan)

• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and in the development of the Source Data Verification (SDV) plan and other applicable Operations documents

• Provide input into non-drug project work including training activities, and development of procedures as needed

• Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools

• Ensure the supply of study materials and Investigational product liasing with Investigational Product Supply 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 meetings, Investigator Sponsored Study Review)

• Monitor study conduct and progress, proactively identifying, to and resolving with the Study Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives

Minimum Requirements –Education and Experience

• Relevant experience of operational activities within a late phase study team.

• Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields

• 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. Good knowledge in S

Timmar per vecka: Heltid Tillsvidare

Arbetsgivare Namn: Dfind Science & Engineering AB

Arbetsgivare adress: Östra Hamngatan 23 41110 GÖTEBORG

Form av kontakt:
Birgitta Nyström titel : telefon 1: () telefon 2: () mobil: e-post: birgitta.nystrom (at) dfind.se

Jobb kort beskrivning:
Biologists, botanists, zoologists and related professionals

Land: Sweden

Område: Västra Götalands län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text