Associate Director SMM - Clinical Operations

Are you seeing opportunities in change and get motivated by trying new ways? Do you also have line management experience and want to advance performance and add value to the business? We need you, come be a part of our journey!

The Nordic Site Management & Monitoring (SMM) team is on a constant journey. We want to re-invent our organisation to find new and more effective ways of working in delivering our studies. We want each function to be accountable of their work and processes and every person counts.

SMM Nordic is part of the Development Operations in the global Research & Development (R&D) function. SMM executes and delivers clinical studies. The clinical studies are delivered in close collaboration with partners in health care and academic medical institutions. Our team works flexible with base in Gärtuna, Södertälje in Sweden and Ballerup, Copenhagen in Denmark . The Associate Director SMM (ADSMM) will preferably be located in Gärtuna and will report to the Nordic Cluster Director (CDSMM), located in Gärtuna.

The ADSMM is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines aligning with AZ Procedural Documents, international guidelines such as ICH-GCP - as well as relevant local regulations. An important part will be the responsibility for line managing dedicated group(s) of staff and responsibility for planning and utilization of staff resources, assigned budget, objective setting, development plans and performance follow-up.

What you'll do:
As ADSMM you will in this role ensure that study start-up is efficient and fully compliant and that clear administrative processes and responsibilities are developed and maintained. In start-up and during the study you will assure that your team of study administrators and start-up specialists become key players in the study delivery and local study teams. A great part of the role will be to develop and manage procedures and oversee quality. You will also manage and mentor a dedicated group - building the team spirit, developing team style and behavior. You will be responsible for the development and performance management of direct reports, ensure that the workload for your group is adequate and make sure that the employees have development and training plans.

Main responsibilities:

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Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
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Contributes to the quality improvement of the study start-up and administrative processes as well as other procedures. Supports SMM EU region in initiatives/activities as agreed with CDSMM.
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Performs quality activities in accordance with the local QC Plan, supporting ongoing coaching and development.

Essential in this role:

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Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
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Minimum 5 years of experience in Clinical Operations (CRA / Sr. CRA / LSM) or other related fields.
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Excellent knowledge and recent experience of EC submissions, budget & contract negotiations and site payment procedures across Nordic countries, financial systems (e.g. SAP, iBuy, ePay), eTMF and archiving requirements.
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Line management experience and excellent interpersonal skills.
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Proven experience in clinical process development and maintenance.
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Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
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Ability for national and international travel.

The successful candidate also has experience in working collaboratively in an environment of remote collaborators with proven team building skills also in cross-functional teams. You have great organizational, analytical and negotiation skills - as well as demonstrate fluent written and verbal communication in English.

Desirable in this role:

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Excellent knowledge of the clinical study process and international ICH-GCP guidelines.
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Excellent knowledge of quality oversight including quality control procedures.
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Good knowledge of relevant local and international regulations.
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Ability to deliver quality according to the requested standards and ability to work according to global standards.
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Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
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Ability to contribute to high quality feasibility work and ensure collaboration with local Medical Affairs team.

Why AstraZeneca?
When we see an opportunity for change, we seize it and make it happen, because any opportunity can be start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey in finding new ways to work, pioneering cutting edge methods and bringing unexpected teams together!

If this sounds like the challenge for you - apply today!

We look forward to your application no later than 25th October 2020.

For more information about the position please contact hiring manager Anna Koch (Cluster Director SMM Nordics) at anna.koch@astrazeneca.com.