Study Management and Monitoring Associate
AstraZeneca Göteborg / Apotekarjobb / Mölndal
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hela Sverige The frontiers of science are changing faster than ever. And AstraZeneca is setting the pace. Be part of a game-changing, high-performing business and unleash your potential to unlock what science can do.
We are now looking to hire a Study Management and Monitoring Associate to pur site in Gothenburg, Sweden.
As Study Management and Monitoring Associate you will work within the Early Clinical Development (ECD) function within the Innovative Medicines (IMED) science unit. You will be accountable for assisting the Associate Directors Study Management to fulfil their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes.
In this varied role, the accountabilities will differ depending on the nature of the clinical programme, as such a high degree of flexibility is required. Part of the role also involves managing the set-up and monitoring of clinical sites, as the individual will be assigned as the Clinical Research Associate for specific sites
Main Duties and Responsibilities
In what is an innovative approach, your role as a Study Management and Monitoring Associate will be broad in remit. You will contribute to the development of study documents as appropriate as well as any updates/amendments to those documents, whilst also ensuring the adequate and prompt supply of study materials and investigational product across the study and at sites where the individual is assigned as the Clinical Research Associate (CRA), by liaising with Investigational Product Supply and external service providers as appropriate.
Other key accountabilities include;
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact the 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, at study, country and site level (for sites where the individual is assigned as the CRA). Maintain the Investigator Study File (ISF) for sites where the individual is assigned as the CRA.
• Initiate and maintain production of study documents, ensuring template and version compliance.
• Contribute to and ensure timely preparation of site financial agreements and country specific CSA, confidentiality agreements, clinical trial applications, the local monitoring plan and other applicable operational documents.
• Lead the set-up of assigned study sites, including contribution to ... FOR FULL JOB DESCRIPTION AND TO APPLY VISIT OUR WEBSITE.
Essential Requirements
To be considered for this role, it is expected that you will hold a University degree in a related discipline, preferably in medical or biological sciences, or a discipline associated with Clinical Research. You will need to hold a good understanding of the drug development process, study management, drug handling and data management. You should also have experience working directly with sites as a Clinical Research Associate (CRA). In addition to this, you should be able to travel to sites for monitoring duties, and have experience working with and delivering using strategic partners and 3rd party vendors.
You should also have an excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP. You will be expected to be fluent in written and spoken English, and be able to clearly 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
• Previous experience in a clinical study coordination or clinical study operations role would be advantageous.
If you are interested, apply now!
Welcome with your application no later than October 1st, 2017.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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.
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We're inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You'll be part of a team that's rolling back the frontiers of science to turn yesterday's impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients - and in return, we'll help you develop way beyond what you thought possible.
Publiceringsdatum2017-09-15Så ansöker duSista dag att ansöka är 2017-10-01
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Pepparedsleden 1
43183 MÖLNDAL
KontorsadressPepparedsleden 1
Jobbnummer 3699396
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