Study Management Associate

AstraZeneca AB / Biomedicinjobb / Göteborg
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Do you have experience in clinical study management and would like a role where your expertise, as well as your leadership skills, will be highly appreciated? Are you team oriented and do you, as we do, put patience first in your work to make a difference? Then AstraZeneca might be the right place for you to contribute and thrive.

We are recruiting for a Study Management Associate (SMA), who will join our BioPharmaceuticals R&D Study Management Early team - as a part within the Development Operations function. The position will be based on one of our vibrant R&D sites in Gothenburg, Sweden; Cambridge, UK or Gaithersburg, US.

In the position as Study Management Associate (SMA), you will support the delivery of global early clinical studies from study set-up through maintenance, close-out and study archiving. It is a role where you work cross-functionally with internal and external partners to lead and deliver aspects of the clinical study according to applicable trial regulations (ex ICH-GCP), AstraZeneca Standard Operating Procedures (SOPs), and in line with AstraZeneca's policies and values.

BioPharmaceuticals Study Management Early, are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within CVRM, RIA and Infectious Disease.

Responsibilities in the role:

In the position as Study Management Associate (SMA), you will play a key role in the study team and assist the study leader to fulfil their accountabilities through coordinating activities that ensures quality, consistency and integration of study data. You will maintain and facilitate interactions with both internal & external functions to provide oversight and ensure efficient study delivery to time, costs and quality objectives, in both internally-run and outsourced studies. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.

The responsibilities will also include:

* Support the Study leader in project management as per agreed delegation.
* Lead to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents such as specifications, study specific procedures, contracts etc.
* Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
* Proactively contribute to risk and issue identification, identification of critical to quality factors, development of mitigation and/or action plans for identified risks and issues.
* Adhere to AZ SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
* Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager.

To succeed in the role, we also believe that you are team oriented and have ability to prioritize appropriately and manage multiple deliverables. We would like you to have demonstrated leadership skills and hope that you enjoy managing change and actively seek and champion more efficient and effective processes. You work independently and have good communication, collaboration and interpersonal skills.

Essential Requirements:

* University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
* Experience from pharmaceutical industry and/or clinical trial experience.
* Good understanding of the drug development process, study management, drug handling and data management as well as deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
* Proven organizational, time management and analytical skills; demonstrate very high quality in English, both in written & verbal communication.

Desirable Requirements:

* Working experience from early clinical studies
* Knowledge about our therapeutic areas (CVRM and/or RIA)
* Experience from independently leading workstreams within clinical studies
* Experience from working with third-party vendors from set-up through maintenance to closure

If this sound like the challenge for you, we look forward taking part of your application no later than November 24th, 2019.

For more information about the position please contact Hiring Manager, Lisa Harlin (Associate Director Study Operations) at

AstraZeneca is acting as an Employment Agency in relation to this vacancy.

Varaktighet, arbetstid
Heltid Permanent

Publiceringsdatum
2019-11-01

Ersättning
Not Specified

Så ansöker du
Sista dag att ansöka är 2019-11-29
Klicka på denna länk för att göra din ansökan

Företag
Astrazeneca AB

Arbetsgivarens referens
Arbetsgivarens referens för detta jobb är "R-064931".

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Astrazeneca AB (org.nr 556011-7482)

Arbetsplats
AstraZeneca

Jobbnummer
4903267

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Study Management Associate

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