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Job #02810

About our client Our client is a global pharmaceutical company headquartered in Thornhill that is focused on the development and manufacturing of various dermatology therapeutics. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Clinical Site Manager Toronto, Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage and monitor clinical trial activities at Investigator sites 2) Ensure the conduct of high-quality clinical trials according to ICH-GCP guidelines and Medical Department’s international and national Standard Operating Procedures 3) Implement and manage a communication network to develop a regional plan 4) Identify and build a database of potential investigators in local regions 5) Arrange appointments and visit potential investigators to build rapport 6) Identify levels of interest between the sponsor and the Investigator 7) Conduct pre-study assessment visits explaining the study protocol and assess the site facilities 8) Identify potential study sites and contact the Investigator 9) Evaluate the available patient population for the study and discuss the obligations of the Investigator and staff 10) Assess the time and ability of the Investigator and staff to complete enrolment within the protocol time frame 11) Assist the Project Team with the preparation and presentation of training tools at central/regional investigator meetings as well as pre-study and initiation meetings 12) Provide early operational inputs regarding the informed consent approval process and the ethics submissions for local IRBs 13) Contribute to the project teams by representing the field and providing feedback to the Project Manager regarding draft documents, validation checks, specifications as well as obvious corrections 14) Demonstrate technical competence and assist with user acceptance along with implementation of electronic data capture at sites 15) Ensure that the Investigator and site staff is adequately trained on protocol requirements, the investigational product, regulatory obligations as well as AE and SAE reporting 16) Discuss and manage the study budget with the Investigator 17) Handle direction of study patients’ payments 18) Ensure the collection of study documentation 19) Verify the storage of all investigative products as per specifications during the study 20) Ensure that sites have the supplies necessary to perform the study 21) Verify proper completion of the CRFs and validate CRF data against the appropriate patient medical records 22) Prepare sites for pre-study visits and the initiation visit 23) Manage, monitor, and report on the progress of the trial at assigned sites 24) Ensure that sites obtain and document proper informed consent 25) Consult regularly with the Investigator at the sites concerning recruitment, retention strategies, and other matters relating to the trial 26) Liaise with the Investigator and the company to ensure open communication, learning, and motivation 27) Identify and be proactive in dealing with site issues (providing intervention and feedback) 28) Close each assigned site when appropriate as per SOPs 29) Attend local and international training, including participation in the audit process 30) Assist in the training of other site managers 31) Perform other duties as required Requirements 1) B. Sc. or equivalent 2) Minimum 5 years of CRA or a related research experience 3) In-depth knowledge of ICH-GCP guidelines 4) Excellent leadership, negotiation, and problem-solving skills 5) Innovative thinker 6) Superb interpersonal skills with ability to build good, working relationships with different kinds of people 7) Ability to work well independently as well as a member of the team 8) Access to broadband Internet service 9) Excellent communication skills (verbal and written) 10) Bilingual – English and French (oral and written skills) 11) Ability to travel and a valid driver’s license