Director, Clinical Trial Management
ICON Clinical Research - United States

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004821

Description

Director, Clinical Trial Management

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

To lead and effectively manage a group of global Clinical Trial Managers (CTMs) of various levels of seniority. To direct the CTMs in a manner that ensures all project timeframes and targets are met and that costs are kept under control and issues are mitigated and escalated as appropriate

Overview of the Role

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Recognize, exemplify and adhere to ICON's

values which centers around our commitment to People, Clients and Performance.

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As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

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  • Travel (approximately 25%) domestic and/or international
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Develop, motivate and mentor CTMs in multiple locations, as required

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Manage all staff under his/her jurisdiction, including:
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Ensuring all necessary training is provided to assigned staff to improve their job performance and knowledge.

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Conducting performance appraisals and efficiently assigning responsibilities for these individuals

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Ensuring staff operate in a professional and client orientated manner

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Direct CTMs to ensure Clinical Operations aspects of projects are conducted in an effective manner, meeting key metrics, milestones, contractual obligations, and expectations in adherence with ICON SOPs, appropriate regulations and ICON’s quality standards.

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Ensuring CTMs adequately evaluate probability and impact of risk, develop and implement quality and risk management plans for minimizing impact on project objectives and deliverables, and effectively manage project budget towards expected profitability

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Actively supporting staff with change management

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Acting as a role model for CTMs

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Optimize staff utilization/recovery

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Ensure staff turnover levels are kept < 15%

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Ensure adequate succession planning of staff

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Proactively participate in the selection and recruitment of suitable and qualified staff

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Participate in trainings as a presenter/facilitator.

Assist with management training for other departments as Clinical Operations representative, as necessary

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Act as the deputy/designee for Clinical Operations senior management, as required

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Proactively identify process improvement and participate in process improvement initiatives as appropriate.

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Liaise with other managers to improve the effectiveness of the organisation

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Monitor the quality specification within project(s) and CTM department

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Function as a key, senior level liaison for ICON with one or more clients including participation in client operational governance committees, as appropriate.

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Other duties as assigned

·

Develop, motivate and mentor CTMs in multiple locations, as required

·

Manage all staff under his/her jurisdiction, including:
·

Ensuring all necessary training is provided to assigned staff to improve their job performance and knowledge.

·

Conducting performance appraisals and efficiently assigning responsibilities for these individuals

·

Ensuring staff operate in a professional and client orientated manner

·

Direct CTMs to ensure Clinical Operations aspects of projects are conducted in an effective manner, meeting key metrics, milestones, contractual obligations, and expectations in adherence with ICON SOPs, appropriate regulations and ICON’s quality standards.

·

Ensuring CTMs adequately evaluate probability and impact of risk, develop and implement quality and risk management plans for minimizing impact on project objectives and deliverables, and effectively manage project budget towards expected profitability

·

Actively supporting staff with change management

·

Acting as a role model for CTMs

Role Requirements

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To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Track record of successfully managing the Clinical Operations aspects of regional/global studies/programs.

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Strong domestic and international clinical trial

management experience

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Minimum of ten (10) year of clinical research experience with at least eight (8) years of clinical trial management experience

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Strong leadership skills, prior successful experience in mentoring CTMs, demonstrated project management ability as well as a positive approach in managing staff, clients and project related issues are necessary to perform successfully in a service-oriented environment.

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Proven track record in successfully managing change.

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Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.

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Fluent in written and spoken English.

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Computer literate.

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Ability and willingness to travel approximately 20% of the time (international and domestic; fly and drive).

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Extensive use of telephone expected

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.

This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

  • LI-ZS1
Job

:

Clinical Operations

Primary Location

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US-Any US location

Organization

:

Clin - Clinical Trial Mgmt

Job Posting

:

03/Jul/13, 8:47:33 AM

ICON Clinical Research - 12 months ago - save job - block
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About this company
41 reviews
Contract research organization (CRO) ICON is not iconic yet, but it would like to be. By the time a new drug hits the market, it has passed...