Senior Specialist Study Management, Gothenburg

Job description
Global Study Manager

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 patients 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 Global Study Manager who will join our Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team – which forms part of BioPharmaceuticals Clinical Operations . The position will be based in our vibrant R&D sites in Gothenburg, Sweden.

In the position as Global Study Manager 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.

Study Management CVRM, are accountable for delivering high quality, cost efficient clinical studies (phase 1 to phase 3) that support drug development within Cardiovascular Renal Metabolism (CVRM).

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
What you’ll do:
In the position as Global Study Manager you will play a key role in the study team and work closely with the Global 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:
To support the Study leader in project management as per agreed delegation.
Lead 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.
Management of study vendors….
To 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.

Qualifications
Essential Requirements:
Experience working within a global clinical study team and managing third party vendors.
Experience working with country/regional study teams.
University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
Experience from pharmaceutical industry and 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:
Knowledge about our therapeutic areas (CVRM )
Experience from independently leading workstreams within clinical studies


About the company
About randstad life sciences
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Deadline: 2023-06-17, selection and interviews will be ongoing.
For more information: Please contact Katan Ali, katan.ali@randstad.se