15 Nov

Study Management Associate Jobs Vacancy at Astrazeneca Royston

Position
Study Management Associate
Company
Astrazeneca
Location
Royston ENG
Opening
15 Nov, 2018 29 days ago

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.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

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.


Key Accountabilities

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

  • Flexibility

  • Ability to manage multiple deliverables

  • Team oriented

  • 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.


Jobs Vacancy Related to Study Management Associate:

21Nov

Clinical Trial Management Associate Jobs Vacancy at Gilead Sciences Stockley Park. Gilead Sciences Stockley Park opening great career opportunity and jobs vacancy for Clinical Trial Management Associate position. This jobs vacancy will be open for new jobs applicant starting for 21 Nov, 2018. Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and... ... Continue reading -->


12Nov

Clinical Trial Management Associate Late Phase Jobs Vacancy at Gilead Sciences Stockley Park. Gilead Sciences Stockley Park opening great career opportunity and jobs vacancy for Clinical Trial Management Associate Late Phase position. This jobs vacancy will be open for new jobs applicant starting for 12 Nov, 2018. Clinical Trial Management Associate – Late Phase. Provides administrative assistance in site selection, study implementation and ongoing coordination of study... ... Continue reading -->


20Nov

Associate Operations Manager Jobs Vacancy at University College London London. University College London London opening great career opportunity and jobs vacancy for Associate Operations Manager position. This jobs vacancy will be open for new jobs applicant starting for 20 Nov, 2018. The postholder will hold a qualification or have considerable experience in operations management or project management.... ... Continue reading -->


04Oct

Data Entry Associate Jobs Vacancy at Hvivo London. Hvivo London opening great career opportunity and jobs vacancy for Data Entry Associate position. This jobs vacancy will be open for new jobs applicant starting for 04 Oct, 2018. Document creation and QC review, study filing, data reconciliation, query management and status reporting. To enter study data into data management or other... ... Continue reading -->


28Nov

Research Assistant Jobs Vacancy at University Edinburgh Edinburgh. University Edinburgh Edinburgh opening great career opportunity and jobs vacancy for Research Assistant position. This jobs vacancy will be open for new jobs applicant starting for 28 Nov, 2018. Research Assistant/Research Associate. The Royal (Dick) School of Veterinary Studies. Experience with use of the Tick@Lab electronic management system.... ... Continue reading -->