Clinical Project Manager

We are now looking for a Clinical Project Manager to manage our next pivotal registration trial for CE-mark approval of SiPore15® for blood sugar control in prediabetics and early diagnosed type 2 diabetics.

About the company
Sigrid is a clinical-stage biotech company driven by the vision to improve human health through material based innovations. We are pioneering a new class of engineered materials to prevent and treat lifestyle disease more safely than existing solutions on the market. Sigrid Therapeutics AB (Sigrid) was founded in 2014 by Prof. Tore Bengtsson and Ms. Sana Alajmovic, with the vision of transforming the way we prevent and treat our modern day chronic lifestyle diseases. The Company's research dates back to 2008 when Prof. Tore Bengtsson and his research group at the Department of Molecular Biosciences at Stockholm University made discoveries relating to improvements in measurements of metabolic disorders after oral ingestion of engineered silica particles. The Company has since then developed a novel materials platform technology, SiPore™, which targets lifestyle diseases by changing the way our bodies digest food. The lead product candidate, SiPore15™, is being developed as the first therapy acting in the gut to improve blood sugar levels in people at risk of developing diabetes. Sigrid is part of the Karolinska Innovations incubator Drive for promising life science start-ups in Sweden.

What can Sigrid Therapeutics offer you?

The Company has a platform technology and the next exciting trial in the pipeline is an obesity trial. You will be a part of a very vibrant team, with a lot of responsibility and possibilities to influence. Celebrating birthdays, kick offs and parties is an important break in the work, which the Company joyfully shares on their LinkedIn and Facebook accounts. They believe in Teamwork makes the Dreamwork!

Main assignments

* Reports directly to the CEO
* To lead and manage all aspects of clinical studies according to the clinical development plan and agreed timelines, cost and quality
* To follow-up study deliverables and ensure appropriate contingency plans are in place
* To manage the contact of identified areas of responsibility between the CRO and the client company and follow up on CRO performance
* To coordinate and contribute to the compilation of critical study documents e.g., Clinical Study Protocols, Protocol Amendments, CRFs, Patient Information Documents and Clinical Study Reports as required
* To coordinate the clinical activities with respect to Investigational Medical Product (IMP) e.g., ordering, labelling, extension of expiry date
* To work with the Clinical Outsourcing Manager with management of delegated CRO Contracts and Amendments related to the study including identifying change of scope requirements
* To directly liaise with the Contract Manufacturing Organisation and the Material Packaging companies on the overall production of the study materials, type of formulation, quality of material etc.
* Organizing and maintaining tracking systems and tools to support the study
* Pre-approve payments, follow-up costs for clinical study activities and track performance of external service providers
* Develop and execute high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies.
* Identify and select Service Providers (SPs) and clinical sites.
* Develops and disseminate Requests for Proposals from Service Provider's and will manage Service Providers including training and oversight, and serves as the primary point of contact for SPs.
* Draft and coordinate the review of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports.
* Maintain program timelines, develops study budgets, and coordinates review of data listings and prepares interim/final clinical study reports.
* Contribute to development of abstracts, presentations, and manuscripts and may contribute to the development of clinical trial management best practice processes and SOPs.


Requirements


* University degree in Life/Health Sciences
* A thorough knowledge of all aspects of the clinical study process
* Several years' experience of conducting and managing clinical studies from the pharmaceutical/biotech industry, preferably from medical devices
* Experience of clinical study protocol and clinical study report writing
* Experience of managing external service providers
* Documented project management skills
* Excellent command in English, written and spoken


Personal Competencies

* Excellent written and oral communication abilities
* Demonstrated ability to lead and motivate teams
* Excellent problem solving skills, and proactive approach to study management
* Strong individual initiative, drive, organization skill and multi-tasking abilities
* Hands-on approach, with a high level of pro-activity, commitment and energy
* A results-orientated person who sees the key issues within the whole picture and still the ability to focus on details.