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We are seeking a dynamic senior Study/Trial Manager (CSPM) to lead our clinical trials with precision and expertise initially for a period of 6 months (with a view to potentially transition to a ...
This role involves overseeing the clinical development strategy, clinical study concepts and ... of the Global Trial Optimization function through process initiatives and change management ...
Manage the clinical trial as required, providing adequate guidance, training and mentoring to ensure that the study is completed to the higher standard, to protocol and fully compliant. You * Valid ...
The Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to inform the clinical development strategy, clinical study concepts, study protocols and operational ...
Responsibilities Clinical Trial Conduct and Management: · Assist in the preparation of clinical trial documentation (e.g., regulatory submissions, study protocol update, IMPD amendment, etc.) · ...
In addition, they will have proficiency in industry-standard clinical database applications, such as Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS). Experience with ...
... trial. The ideal candidate will be 0-5 years PQE and have experience handling a caseload of ... Prioritise and manage a varied caseload * Ability to work well as part of a team and on your own ...
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans and local regulatory requirements. * Implement product related ...
Ensuring global clinical trial material supply for assigned studies. * Facilitating timely startup of new studies through prompt supply availability. * Managing clinical packaging and distribution ...
Provide assistance in managing the contracting process and processing change orders; * Review the ... Our services include Expanded Access Programs (EAPs), Named Patient Programs (NPPs), Clinical Trial ...
With a rich blend of expertise in Clinical Development, Clinical Trial Supply, and Early Access ... Lead and manage projects involving Real World Evidence (RWE), integrating these insights with ...
You will act as the primary Data Management Lead for assigned projects, take responsibility for resourcing and planning and carry out leadership and management of projects and clinical trial data ...
Create clinical trial packaging documentation including specification, labels, blinding strategies, randomisation, batch packaging records, dispatch and returns. * Manage timely receipt and release ...
Strong understanding of clinical trial design, execution, and regulatory requirements, preferably ... Proven leadership skills with the ability to effectively manage cross-functional teams and drive ...
... Trial obligations, reporting to the Director of Clinical QA. You will work closely with Clinical ... Time management skills * Demonstrated strong work-ethic * Outstanding customer service approach
You will manage a full portfolio of projects/studies across multiple therapeutic areas. You will ... Background in clinical trial protocol development * Excellent knowledge of the current market is ...
Manage regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements. * Implement product related ...
Plan and manage regulatory submissions for clinical trial and marketing applications in compliance with global filing plans and local regulatory requirements. * Regulatory Strategy Implementation
Background in clinical trial management * Experience in Regulatory Affairs * Good level of knowledge of Clinical Trial Submissions on a local and regional level * Working knowledge of submissions ...
The Process Development Scientist will manage and oversee the day-to-day operations of process ... Clinical Trial Support: Continue the development process as new ATMPs advance from early to later ...
Biopharmaceutical industry experience and some knowledge and understanding of Clinical trial execution. * Budget and project management experience preferred. * Experience with Project Management ...
... clinically studied ingredients in the most comprehensive formulas, with therapeutic dosages ... Define specific customer (Retail & DTC) engagement strategies to increase awareness and trial of DR
Regularly check clinical trial processes, documents, and systems to find areas that don't comply and make necessary changes. * Work with different teams to develop and maintain quality management ...
Generate, analyse and interpret clinical trial data. * Develop and manage relationships with external KOLs. * Provide internal coaching and leadership to the medical affairs team. Your Background