Local Study Manager

3 weeks ago

Mississauga, Canada GSK Full time

**Site Name**: Canada - Ontario - Mississauga

**Posted Date**: Feb 6 2023
- Are you energized by the challenge of executing and delivering in-country oncology trials and being ambitious for patients, while shaping and accelerating scientific expertise? If so, the position of Local Study Manager, Oncology may well interest you._

**Job Purpose**:
The Local Study Manager (LSM) or Local Delivery Lead (LDL) is accountable for within-country execution and delivery of assigned studies across therapy areas to time, budget and quality as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and GSK written standards. The LSM/LDL serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRAs) / Senior Clinical Research Associates (SCRAs) and other in-country staff aligned to the study.

**Details (Your Responsibilities)**:

- This role will provide YOU the opportunity to lead key activities for in-country execution of clinical trials in Oncology therapy area and to progress YOUR career further. These responsibilities include the following:_
- Accountable for within-country execution and delivery of assigned studies to study timelines, budget and quality expectations as defined in the study protocol as well as in local regulations, IND/ICH GCP guidelines, and GSK written standards.
- Accountable for completeness of local trial master file for internal compliance, external regulatory or Canada Revenue Agency audits. Acts as point of conduct for trial assessment or inspection.
- Responsible to provide leadership and drive decisions related to the conduct of a clinical study locally including escalating issues when required.
- In collaboration with global and local matrix teams and functions (Quality Assurance, Regulatory affairs, Clinical Supplies, Procurement, Contracts, Legal, Monitoring, Data Management, Medical Affairs and Vendors) leads the development of site selection strategy (single or multiple study programs), local model informed consent form, local investigator meeting planning and oversight of training delivery, study performance and risk management, budget development and oversight of payments to sites and vendors.
- Responsible for matrix leadership and project management of country and site-level activities including oversight of site management & monitoring activities within their Local Operating Company, including timely Monitoring Visit Report review.
- Serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) and other in-country staff aligned to the study.
- Responsible for identification and sharing of best practices, standardizing across the LOC / region and may be involved in internal / external process improvement teams.

**_Why you?_**

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Scientific degree or equivalent experience (e.g. life science, medicine, clinical research, pharmacy etc).
- Experience in clinical development or equivalent experience in the pharmaceutical or health-related field.
- Ideally, a minimum of -1-3 years clinical research experience in Oncology (experience may have been in Study Management, Field Monitoring or similar experience gained at another company);
- Demonstrates a very good level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements.
- Knowledge/experience in project management and matrix team interactions.
- Excellent English language written and verbal communication skills. Strong negotiation skills.
- Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook).
- Effective at problem solving and conflict resolution.
- Flexible with high learning agility.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Masters of Science or equivalent. Advanced degree preferred but not essential (e.g. life science, medicine, clinical research, pharmacy etc).
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
- Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
- Demonstrates the discipline of risk-based planning, organizing and managing risks / contingency planning to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics.
- Exhibits strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available); projects, manages and reports budget information (i.e., demonstrates business a

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