Sarah Cannon Network Job - 30953545 | CareerArc
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Company: Sarah Cannon Network
Location: Nashville, TN
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Description

SHIFT: Work From Home

SCHEDULE: Full-time

Manager - 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 the clinical data management function of Sarah Cannon Development Innovations. This includes all activities performed by Clinical Data Managers and Clinical Data Analysts. This position ensures proper resources are trained and available for all projects. This position must clearly demonstrate managerial and leadership skills and have excellent organizational abilities. This position must also have the ability to manage the technical aspects of data management systems used at Sarah Cannon.

Duties and Responsibilities Duties include but are not limited to:
  • Reviews and approves Data Management Plans for all trials
  • Reviews and approves Case Report Forms and Completion Guidelines for all trials
  • Promotes and enforces responsible use of data standards
  • Ensures resources are trained and available for all data management projects
  • Builds and maintains relationships with programming team to ensure optimal performance
  • Drives efficiency by identifying and creating solutions and tools.
  • Manages data management colleagues including hiring, performance management training, and resource allocation
  • Forecasts resources
  • Ensures database designs and data operations are consistent and conform to standard processes
  • Ensures proper documentation is filed in the Trial Master File
  • Represents Data Management with sponsors for business development activities
  • Participates in budget development both for projects and for the department budgets
  • Liaise with cross functional team and external contacts to execute all aspects of data management trial delivery
  • Ensures data management problems are identified early in the lifecycle and are followed through to resolution
  • Manages vendors for systems and software used by Data Management
  • Serves as Project Manager for studies with only Data Management services
  • Writes SOPs and Job Aids
  • Ensures the integrity of data, providing recommendations for corrective action when necessary
  • Ensures all deliverables are on time and on budget for all data management projects
  • Keeps management abreast of issues, progress, and risks related to trial operations
  • Delivers excellent customer service
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 available resources
  • 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

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

Qualifications

Minimum Qualifications Education:

Minimum Required: Bachelor's 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
Preferred:
  • Direct Supervisory experience
  • Experience in resource allocation models
  • Oncology experience

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


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