Study Management Associate Jobs Vacancy at Astrazeneca Royston
Astrazeneca Royston urgently required following position for Study Management Associate. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Study Management Associate Jobs Vacancy at Astrazeneca Royston Jobs Details:
Study Management Associate
Cambridge or Gothenburg
At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together.
We are looking to recruit a talented Study Management Associate (SMA) to join our Innovative Medicines Early Development (IMED) organisation. The Study Management Associate is accountable for assisting Associate Directors Study Management and Study Management Leads fulfil their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes and providing administrative support. The exact accountabilities will differ depending on the exact nature of the clinical programme so a high degree of flexibility is required.
As a SMA, your role will be varied and broad, however it will typically involve the following accountabilities;
Contribute to the development of study documents as appropriate as well as any updates/amendments to those documents
Lead the preparation of country specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents.
Contribute to review of new/amended/unique SOPs and guidance documents
Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate.
Support the study delivery team in the implementation of audits and regulatory inspections
Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents through finalization of the protocol through to the Clinical Study Report (CSR) and administrative appendices
Maintain and close the TMF, ensuring continual inspection readiness
Initiate and maintain production of study documents, ensuring template and version compliance
Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data
Prepare presentation material for meetings, newsletters and web-sites
Required Experience, Skills, and Qualifications
To be considered for this position, it is expected that you should have a University degree in a related discipline, preferably in medical or biological science, or one related to Clinical Research. You should have a deep understanding of the drug development process, study management, and data management, as well as an excellent knowledge of ICH-GCP, coupled with familiarity with GMP/GDP. You should be fluent in written and spoken English, with experience of working with and delivering through strategic partners and 3rd party vendors. To be successful in this role, you will need to demonstrate the following behaviours;
Ability to prioritise
Ability to manage multiple deliverables
Ability to manage change and actively seek and champion more efficient and effective methods / processes
Good communication, negotiation, collaboration and interpersonal skills
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.