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Associate Director, Clin Data Mgmt

Covance 11/13/2018 7:40:26 AM
JOB ID: 25235 Category: Clinical Data Management
Chicago, Illinois

   

 

Job Overview

Associate Director, Clinical Data Management

Office or Home-Based anywhere in the USA or Canada

Covance is seeking an Associate Director, Clinical Data Management to be responsible for delivering data management services to clients and project teams, management of staff and contractors, and maintenance of optimal department processes while implementing excellent project-specific strategies; develop and maintain close positive relationships with counterparts within client organizations: Project Managers, core project team members and others to drive collaboration, consistent expectations, proactive management of risks, productive interdepartmental communications and excellent project delivery; and provide leadership and supervision of data management study/project leaders as well as junior staff, ensuring effective implementation of project and individual goals, development strategies, mentoring, performance management, recruitment and retention strategies,

Additionally, the selected candidate will:

* Staff and serve as a strong member of the local/regional leadership team. Promote staff development, career and succession planning, improvements in interpersonal and leadership skills, and achievement of competency standards.
* Lead/support the implementation of short-term and long-term strategies to improve data management efficiencies (locally and/or regionally) through collaboration with senior management and peers from other sites.
* Lead and/or provide direct oversight of CDM study teams to achieve goal of "delighting clients" through delivery of quality processes and outcomes, on-time and in budget.
* Serve as a "Change Agent" — demonstrating support and personal leadership to help others adapt to business processes improvement, uptake of new systems, and other departmental and organizational initiatives and effectively managing potential change resistance through communication and coaching.
* Prevent and/or deal decisively and effectively with obstacles that put achievement of goals at risk, including poor performers, attrition, peaks/valleys of work volume, project scope changes, and the myriad of issues that are common to clinical trials (delays, systems glitches, errors, audits, shifting deadlines, misaligned expectations, etc...)
* Support definition and implementation of global, harmonized SOPs, processes and standards, and ensure staff members are trained and that standards are applied within your group.
* Lead and collaborate with subordinate Team Leaders and colleagues from other functions to identify and implement solutions to data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
* Support business development and marketing activities at client presentations and professional seminars and coach junior staff to develop the skills to do likewise.
* Support processes, DM work assumptions and prepare and present to potential clients on data management capabilities and train others within the department to provide these services.
* Act as an advisor/collaborative partner with counterparts from other functions (Project Management, Monitoring, Site Support Services, Biometrics, Drug Safety, Regulatory, etc.). to devise business strategies and/or work through issues where a CDM perspective may add value.
* Work with Regional/Site Director and peers to review productivity, quality, and financial indicators for the regional data management group and decide/act to improve as applicable.
* Manage CDM project budgets in accordance with project strategy — responsible to deliver quality CDM services against the backdrop of meeting departmental utilization targets and managing discretionary spending.
* Network with peers, participate in professional meetings, review literature, and research processes, standards, technologies, etc... for improving practices and efficiencies while representing Covance as a leader in the field of Data Management.
* Perform other duties as assigned by management.
* Support business development and marketing activities at client presentations and professional seminars and coach junior staff to develop the skills to do likewise.
* Support processes, DM work assumptions and prepare and present to potential clients on data management capabilities and train others within the department to provide these services.
* Act as an advisor/collaborative partner with counterparts from other functions (Project Management, Monitoring, Site Support Services, Biometrics, Drug Safety, Regulatory, etc.). to devise business strategies and/or work through issues where a CDM perspective may add value.
* Work with Regional/Site Director and peers to review productivity, quality, and financial indicators for the regional data management group and decide/act to improve as applicable.
* Manage CDM project budgets in accordance with project strategy — responsible to deliver quality CDM services against the backdrop of meeting departmental utilization targets and managing discretionary spending.
* Network with peers, participate in professional meetings, review literature, and research processes, standards, technologies, etc... for improving practices and efficiencies while representing Covance as a leader in the field of Data Management.
* Perform other duties as assigned by management.

Education/Qualifications

Minimum Required:

* University/college degree (life science, pharmacy or related subject preferred), certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology), or relevant Experience .
* Must have broad knowledge of drug development processes with particular expertise in clinical trial data handling practices and relevant regulations.
* Understanding of clinical development budgets and relationship to productivity targets.
* Thorough knowledge of effective data management practices.
* Expertise in resource management within a CRO setting.
* Thorough knowledge of time and cost estimate development and CRO service pricing strategies.
* Thorough knowledge of ICH Guidelines and GCP including regional regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Experience
-
Minimum Required:

* Minimum seven (7) years of relevant work Experience with four (4) or more years supervisory Experience to include data management, clinical operations, biostatistics or related field and knowledge of several therapeutic areas.
* Demonstrated skill for management of staff exceeding 10 employees across one or more locations within a region (Europe, North America, Asia-Pacific etc.).
* Excellent oral and written communication and presentation skills.
* In depth knowledge of clinical trial processes and data management, clinical operations, biometrics, and systems applications to support operations.
* Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
* Operational Experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc.
* Demonstrated ability to lead change by example and achieve results.
* Demonstrated ability to handle multiple competing priorities simultaneously across an assortment of projects and initiatives.
* Demonstrated ability to inspire effective teamwork and motivate staff.
* Proven managerial and interpersonal skills.


Position Type: Full-Time

Location: Chicago, IL - Illinois



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If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).