The Clinical Study Manager will work on all aspects of clinical development planning, clinical study planning, and study execution. This will include preparation of study related materials, relationship management between study sites and vendors (MCRA), supervision of study related activities, identification of project risks and contingency planning. The position will also have to work closely with Quality Management and R&D.
- Develop, maintain and review budgets, timelines, and forecasts for clinical studies.
- Set-up, plan and coordinate clinical trials through to study closure.
- Provide operational and strategic input into study documents such as synopsis, protocol, completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
- Identify and communicate risks to study timelines and propose mitigation strategies.
- Track study progress reporting progress of studies to internal stakeholders, including patient screening, enrolment, data collection, adverse events documentation, and reporting.
- Develop and approve study-specific documents, tools, presentations, and processes.
- Routinely review data to ensure data integrity, accuracy, and protocol compliance.
- Assist with the management of medical device distribution, receipt, and use.
- Maintain focus on strategic objectives while accomplishing operational goals of execution re GSK requirement.
- Trouble shoot study design.
- Be the key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.
- Manage and track key study metrics to ensure adherence to project milestones, along with communicating with other departments
- Drive activity to ensure that enrolment commitments are met, while also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues.
- Ensure that clinical monitoring activities are performed appropriately, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
Key Knowledge, Skills and Qualifications
- B.Sc. in a field relevant to clinical research
- At least five (5) years of clinical research experience including prior monitoring experience and at least two (2) years of experience acting in a Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
- Proven record of successful execution of clinical trials.
- Strong verbal and written communication skills, including technical writing and the ability to communicate with internal and external customers.
- Computer proficiency (MS Office 365 - Word, Excel, PowerPoint, Access, and Teams).
- Ability to work both independently and collaboratively
- Be self-driven & proactive.
- Time and task management skills.
- Conflict resolution and decision making skills.
Additional Job Requirements
- Ability to work overtime and weekends on occasion.
- Some travel may be required.
Please submit your application through LinkedIn here. We thank all applicants for their interest, however only those selected for an interview will be contacted.
You can learn more about IR-Scientific on their website here.