(WNY85) | Director, Clinical Operations home based Argentina

(WNY85) | Director, Clinical Operations home based Argentina

Description

Director, Clinical Operations home based Argentina
JOB SUMMARY
Manages and provides leadership to Clinical Operations Staff, including the supervision of more senior level clinical operations management positions in the assigned Business Unit and region; areas including Site Selection, Site Activities including On-Site Monitoring and/or Central Monitoring through Study Close Out. Analyzes resourcing capacity and ensures a consistent quality of services and balanced work team. Assures clinical operations delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures.



Liaise with other departments and business units to establish harmonized clinical operations practices, processes and tools. Participates in the financial review of project status and drives project financial performance, particularly as related to clinical operations services.

JOB RESPONSIBILITIES

· Line management of Clinical Operations staff, responsibilities including professional development, performance appraisals, and employee counseling for junior and management staff. Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Manage senior level professional staff.

· Supports the development of the regional staff plan, identifying needs to hire new staff in a timely fashion and oversee the talent acquisition process in the assigned country. Proactively works to ensure staff retention and turnover rates remain within expected levels.

· Manage and control the financial performance in the assigned country(-ies) or region(s) within the assigned Business Unit, ensuring that departmental targets are met for utilization, gross profit,



revenue realization and cost control (including contractor use and staff overheads).

· Provide expert operations oversight and guidance. Sets priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges.

· Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH/GCP. Ensures individual and team tasks are completed according to country specific and government regulations. Ensures all staff follow required training and completes the required documentation.

· Maintains awareness of project resourcing issues, hours and overall workloads. Ensures that project clinical operations goals are met within appropriate timelines.



Provides regular updates to the assigned Business Unit Leadership accordingly.

· Works closely with other departments to ensure quality performance on all studies as well as to correct process deficiencies as identified by staff, customers, and auditors. Assist in the resolution of any project-related issues/findings associated with the performance of Clinical Operations staff in the assigned Business Unit at country and regional level. Participates in committees and work groups to support the development of corporate best practices and processes.

· Provide support to Business Development to facilitate new project awards during the Bid Defense process, providing expert Clinical Operations guidance where required. May participate in marketing activities, customer presentations and proposal development.

Qualifications





QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

· Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required.

· Extensive knowledge of ICH/GCP guidelines and other applicable regulatory requirement

· Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas. Ability to understand, explain and communicate project concepts and put into detailed plans.

· Demonstrated strong leadership, tactical and strategic thinking skills.



Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner. Knowledge of financial concepts as related to forecasting, budgeting, and proposal generation.

· Demonstrated ability to self-direct tasks and set direction and priorities for others to achieve departmental goals.

· Strong time management, technical, and organizational skills

· Must demonstrate proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to gain working knowledge in other applicable business tools and systems.

· Requires above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.



This includes excellent communication and presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

· Ability to travel as necessary (approximately 20%)

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