Director - Clinical Data Management

  • HCA
  • Nashville, TN, USA
  • Dec 24, 2017
Healthcare

Job Description

Job Code: 25319-4412

Full-time

No Weekends

Director/Associate Director - Clinical Data Management

Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.

Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.

Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.

Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.

Summary of Position:

This position is responsible for overall operation of Sarah Cannon Development Innovations Data Management; including Data Management Programming.

Duties and Responsibilities

Duties include but are not limited to:
  • Execute data management activities in accordance with industry-set Data Management Best Practices, Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by Sarah Cannon and its sponsors
  • Provide oversight, leadership and direction in data management and programming services
  • Manage data management and programming personnel; including hiring, performance management, training, mentoring and resource allocations
  • Oversee all assigned clinical trials to ensure data quality, integrity and timeliness
  • Set and track department goals and key performance indicators
  • Develop, review and update SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
  • Manage vendors and vendor contracts associated with data management systems and activities
  • Implement clinical data systems, including electronic data capture (EDC) and data visualization tools
  • Serve as Business Owner of clinical data systems
  • Collaborate with Development Innovations leadership to set global data strategy, including utilization of systems
  • Lead Standards Governance Board to implement and maintain standards across the Data Science organization
  • Represent data management and programming at business development/customer meetings and audits
  • Provide input into and manage department budget
  • Manage financial aspects of clinical trials; proposal, budget and contract development, change orders and personnel time billing
  • Keep management abreast of issues and progress on all projects/initiatives and clinical trials
  • Understand and apply regulatory guidelines/developments and industry standards/best practices in data management and programming
  • Maintain data management and programming acumen in clinical research through education, programs, lectures and publications
Competencies

Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
  • Knowledge of regulatory guidelines (i.e. HIPPA, 21 CRF Part II, GCP)
  • Knowledge of Good Clinical Data Management Practices
  • Knowledge of data management technology
  • Knowledge of budgets and the budget process

Skills: The proficiency to perform a certain task
  • Effective communication skills, oral, written and presentation
  • Organizational skills
  • Problem solving skills
  • Analytical skills
  • Conflict Management
  • Time Management skills
  • Strong decision making skills

Abilities: An underlying, enduring trait useful for performing duties
  • Ability to translate ideas into action
  • Ability to think strategically
  • Ability to work independently to achieve goals
  • Must have initiative and excellent follow through
  • Ability to prioritize effectively
  • Ability to influence peers


Minimum Qualifications

Education:

Minimum Required: Bachelors College Degree (4 year program)
Preferred: Master's Degree (1-2 year program)


Experience:

Minimum Required:
  • Clinical Data Management experience in clinical research industry (sponsor/CRO or combo)
  • Leadership experience, managing a project or a team
  • Technical experience with Data Management tools
  • Oncology experience
  • Direct supervisory experience
Preferred:
  • At least 7 years of clinical research experience
  • System implementation
  • Experience in resource allocation models
  • Data management certification
  • Early phase Oncology experience


**If interested in advancing your career with a growing leader in cancer research please apply today!

Last Edited: 02/05/2018

Reference

25319-4412