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Clinical Trials Network Project Manager
1 month ago
**Company** : IWK Health**:
**Req ID**:142990
**Department/Program**:CCFV, Research Services
**Location**: Halifax
**Type of Employment**:Temporary Hourly FT long-assignment (100% FTE) for one year x 1 position(s)
**Start Date**: ASAP
**Union Status**: Research, Management/Non Union Bargaining Unit
**Compensation**: As Per Health Centre Scale
**Closing Date**: Open Until Filled
IWK Health is a respected academic health sciences centre located in Halifax, Nova Scotia, providing tertiary and primary care for two million children, youth, adults and families each year across the Atlantic region. We have a team of approximately 4000 employees, physicians, volunteers and learners at sites across Nova Scotia. People build careers with IWK Health with our focus on training and mentorship opportunities. We recognize each other’s talent and celebrate our successes. We collaborate in modern facilities or virtually from home, align our work to our values, and enjoy access to enhanced benefits and wellness programs. We are proud to support our patients, families and communities and are grateful for the generous donor support we receive.
**The Opportunity**:
The Clinical Trials Network (CTN) Project Manager reports to the Principal Investigator, CTN, and the Chief Administrative Officer and provides administrative and management support for the entire portfolio of CTN studies, which includes several multi-site clinical trials, both national and international.
The CTN Project Manager is responsible for a wide range of duties including some or all of the following: project initiation, clinical management, virtual team management, research project logistics, research
ethics, project reporting, communications, and liaising with investigators, monitors and study sponsors.
**Responsibilities**:
Planning/Organizing
- Provide overall coordination of assigned studies in accordance with CCfV Standard Operating Procedures (SOPs) and/or sponsor or regulatory guidelines under the guidance of the Principal
- Investigator
- Act as lead to a national network of site research coordinators and various team members for each aspect of various projects
- Develop, review, and approve Statements of Work, contracts, and budgets
- Manage multiple project budgets including development, forecasting, monitoring and reporting to the PI and advising on risk mitigation strategies to achieve sound financial management
- Work with the Laboratory and Data Management teams on all aspects of project logistics
- Act as the primary liaison with sponsor for industry-funded clinical trials
- Review and assist with the development of protocols, Case Report Forms, consent forms, and other study documents
- Assist with planning, budgeting, implementation, and evaluation for CTN studies
- Organize CTN meetings for monitors, investigators and team members in collaboration with CIRN Program Manager and Principal Investigator
- Assist with the writing and review of academic publications, including presentations, abstracts, and manuscripts
- Assist in the preparation of network materials for annual reports and other knowledge translation activities as required
- Work collaboratively with research groups within Canada and internationally to coordinate research projects across multiple sites
- Mitigate and resolve administrative issues across multiple project sites
- Maintain study documentation in adherence with the CCfV filing system
- Maintain a current knowledge of the study status and important milestones
- Maintain up to date directory of all CIRN CTN team members and liaisons
- Liaise with CTN data team regarding data collection, and creation and revision of forms
**Skills, Knowledge, Education and Experience**:
- Experience overseeing coordinating multiple clinical trials at a time
- Extensive project management experience in a clinical or research setting
- Excellent communication and interpersonal skills; able to speak, listen, and write in a clear,
- thorough and timely manner using appropriate and effective communication tools and
- techniques
- Experience leading and/or managing virtual teams
- Ability to work cooperatively and effectively with others
- Demonstrate a high level of time management and decision-making skills in regards to project
- deadlines and milestones
- Highly organized and able to multi-task when needed
- Strong attention to detail
**Your Qualifications**:
- 3+ years of relevant experience within a university research setting, hospital, or comparable environment
- Experience writing, editing, and reviewing protocols and other study related documents
- Understanding of pharmaceutical regulatory environment
- Understands Research Ethics, in concept and practice; demonstrable experience providing budget management and reporting oversight
- Excellent project management skills and experience
- Knowledge of federal, provincial and other private/public funding agencies
- Excellent oral and written communication skills
- Advanced know