Clinical Project Manager

Clinical Project Manager till Sigrid Therapeutics

Hays Life Science is now recruiting a Clinical Project Manager to Sigrid Therapeutics. If you are ready to take the next step in your career with freedom, responsibility and the chance of being involved in all parts of managing the next pivotal registration trial, this is a unique opportunity. To succeed in this role you have previous experience from Clinical Project Management or experience as a Clinical Research Associate with an ambition to further challenge and develop yourself in the Project Management role. At Sigrid Therapeutics you will work in an entrepreneurial and driven organisation. You will be a part of a very vibrant team, with a lot of responsibility and possibilities to influence.


About the company
Sigrid, founded in 2014, 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. 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.


About the role
In this role you will report directly to the CEO and also work closely with a team of experts. Your tasks include:

* 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
* 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.
* 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
* Knowledge of the clinical study process
* Experience of clinical study protocol and clinical study report writing
* Experience of managing external service providers
* Documented project management skills are an advantage
* Excellent in English, written and spoken


Personal Competencies

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