Clinical Data Manager - Work From Home 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.
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. **This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role. Summary of Key Responsibilities:
This position serves as the project manager for all Data Science deliverables. The CDM is the primary contact for the client for all Data Science issues. This is a key role when Sarah Cannon bids on projects - the data manager assignment is included in the proposal to the client. The CDM is accountable to the client and to the Project Manager for the delivery of all Data Science deliverables on time and with high quality. The Data Manager is accountable for compliance to all SOPs and regulatory requirements.
Duties and Responsibilities:
Duties include but are not limited to:
- Leads cross functional Data Science teams (Statisticians, Programmers, Data Manager) to plan for and deliver all data deliverables. This includes creating and managing all timelines and project plans.
- Lead Data Science activities for 4-10 clinical trials. This includes but is not limited to:
- CRF design
- Database design and testing
- Report specifications and testing
- Data Management Plan development
- Development of data quality checks
- Management of data sources from outside vendors
- Delivery of a locked database.
- Management of all mid-study changes to the database
- Represent Sarah Cannon Development Innovations Data Science externally in Business Development activities.
- Represent Sarah Cannon Development Innovations Data Science in the development and implementation of internal process improvement initiatives.
- Participate in the training and mentoring of junior staff including Clinical Data Analysts
- Key liaison with client to ensure the highest possible customer service in order to win repeat business.
- Enforces data standards with project team, physicians and clients.
- Identifies data science scope changes and provides cost analysis to the project manager for these scope changes
- Promotes effective teamwork among members of the data science team
- Directs activities of Clinical Data Analysts
- Communicates and escalates unresolved issues at the appropriate time and to the appropriate level of management.
- Accountable for compliance to all SOPs and regulatory requirements.
- Accountable for ensuring all required documentation is created and filed in the Trial Master File.
- Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
- During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
A body of information needed to perform 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
The proficiency to perform a certain task
- Effective communication skills, oral, written and presentation
- Organizational skills
- Problem solving skills
- Conflict Management
- Negotiation skills
- Strong decision making skills
An underlying, enduring trait useful for performing duties
Qualifications: Education: Minimum Qualifications:
- 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 influence peers
Bachelor's degree (4 Year Program) Preferred:
Master's Degree Experience: Minimum Required:
- Clinical Data Management or other relevant experience.
- Demonstrated success in clinical data management.
- Experience managing multiple teams as well as interdisciplinary teams.
- Experience working with and negotiating with external clients.
- Prior experience with case report form and data specifications creation.
- Prior equivalent experience in managing database systems and teams.