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Clinical Operations Site Manager

Parexel USA

This is a Contract position in Vaughan, ON posted September 21, 2022.

Parexel has an exciting opportunity to advance your career in Clinical Research.

We are looking for a Manager of Clinical Operations to oversee day to day operations in the Glendale, CA Early Phase Clinical Unit while managing both clinical and laboratory staff.

This role ensures that all Clinical Operations, inclusive of Transit Laboratory, Shipping, and Pharmacy work outcomes are timely, efficient and of the highest quality to internal and external clients.

Please note: this role is 100% onsite at our Glendale, CA unit (no remote work) Key Accountabilities : Manages and oversee clinical staff day to day activities providing direct supervision, including but not limited to the following: hiring, training (ensuring tools and support is provided to enable staff to be competent and successful in roles), scheduling, meets regularly with staff and maintains1:1 meetings, coaching/counseling (providing both direction and verifying appropriate completion of tasks), performance management, performance reviews, reviews and approves all timesheets performance reviews to ensure compliance with policies and regulations, escalates appropriately concerns and issues to senior leadership and HR as appropriate.

Identifies, develops and modifies operational systems, training programs, tools, processes and/or materials to optimize staff develop, high performance culture, and streamline operations in the clinic, working closely with the Director, Clinical Operations, Associate Director, and Senior leadership as appropriate.

Meets regularly with Operations Management team (and others as applicable) to proactively plan needs for upcoming studies, including identification of strategies to optimize staffing
– e.g., sharing of staff between departments, harmonization of roles/tasks, or other ways to streamline tasks/operations.

Attends managerial/operational meetings as required.

Possesses thorough knowledge of all current study protocols.

Explores potential in upcoming studies, methods to continue to provide sponsors with the highest quality data, increasing clinic efficiency and directions for future growth.

Provides clinical input on protocols in development and assess feasibility.

Identifies risks and strategies to mitigate risk, and supports leading next steps with implementation.

Evaluates proposed protocols and provides feedback to Business Operations on clinical feasibility.

Provides Department feasibility assessments for study protocols and design when programs are being considered through Business Development.

Provides information to Business Operations/Business Development to complete proposals/budgets as appropriate.

Meets regularly with the Associate Director/Director, Clinical Operations.

Leads departmental meetings regularly as appropriate.

Interfaces with key departments to discuss status of current studies at PAREXEL, as well as strategies for any potential challenges, including but not limit to staffing, vendor or hospital issues.

Manages all aspects of clinical operations at the unit/site.

Supervises additional support staff and ancillary staff as required by the unit/site.

Provides continued contact with the Sponsor for duration of the clinical study including entertaining Sponsor during site visits.

Establishes and maintains relationships with hospital or facility representatives as appropriate.

Negotiates rates with clinical vendors.

Reviews, tracks and approves all Departmental expenses as appropriate.

Works closely with Advertising/Enrollment Departments on recruitment strategy/issues as appropriate.

Reviews Draft consents and offers suggestions to Regulatory Compliance.

Manages all aspects of departmental performance improvement strategies including: identifying areas for improvement, developing action plans in conjunction with all affected areas/staff, tracking results and reporting results to upper management.

Determines the necessity for the creation of departmental Clinical Operating Guidelines (COGs) and Standard Operating Procedures (SOPs) to meet hospital/facility requirements.

Oversees and approves the review, revision, and/or retirement of departmental COGs and SOPs, upon approval, oversees the training and implementation of departmental and inter-departmental COGs/SOPs.

Maintains and updates knowledge of Good Clinical Practices (GCPs)/Good Documentation Practices (GDPs) and their proper application.

Reinforces the use of GCPs/GDPs departmentally through example and staff training.

Maintain a positive, results orientated work environment, building relationships with management, colleagues, and other departments, communicating in an open, balanced and objective manner.

Assumes other duties and responsibilities, as assigned.

The above responsibilities are a general description of the level and nature of the work assigned to this classification and is not to be considered as all inclusive Skills: Demonstrated leadership ability Excellent interpersonal, verbal and written communication skills Client focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork.

Meticulous attention to detail.

Ability to effectively manage time, manage resources and multi-task.

Technical proficiency in applicable systems (Excel, ClinBase, and others as applicable) Knowledge and Experience : 3-5 years Clinical Research Experience Required 2 years Laboratory Experience Education: BS/MS in a related science, BSN, RN or MBA is preferred Management experience