HCA, Hospital Corporation of America Manager of Data Operations for Early Phase Research in Nashville, Tennessee
Sarah Cannon is the research arm of HCA’s global cancer enterprise. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
_Summary of Key Responsibilities:_ Responsible for data operations for a team of Clinical Trials Specialists and Data Coordinators, including direct supervision and development of staff, adherence to standard operating procedures and reporting of data to internal and external groups. Provides leadership in the startup, enrollment, closeout and overall data management of clinical trials. Responsible for establishing effective working relationships within data management team, study teams, principal and sub-investigators, sponsors and other external consultants.
_Duties and Responsibilities:_ Duties include but are not limited to: • Manage performance and professional development of study operations staff. • Create, monitor, document and follow departmental SOPs, WPGs and corporate guidelines. • Plan and track all clinical trial activity assigned to the department, including startup, enrollment and closeout. • Develop status reports based on team metrics and communicate to leadership. • Review proposed clinical trial budgets and protocols; assess feasibility and data requirements prior to initiation as well as on an ongoing basis. • Review all clinical trial contracts to determine data deadline parameters. • Ensure timely and accurate entry of data into assigned databases. • Ensure, review and approve source documentation as required. • Assist in slot management for monthly enrollment to ensure appropriate clinical trials are prioritized and accrued. • Build and maintain strong industry sponsor and internal team relationships to ensure effective communication. • Prepare ad hoc reports for leadership, sponsor, CROs and other individuals/groups as needed. • Maintain positive and cooperative relationships in day-to-day interactions and communications. • Promote effective teamwork among Clinical Trial Specialists and Data Coordinators. • Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of leadership. • Attend and participate in assigned Sponsor meetings as well as internal leadership and team meetings
_Knowledge:_ • Knowledge of FDA guidelines and GCP. • Must be able to read, understand and comply with research protocols.
_Skills:_ • Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access and MS Excel. Abilities: An underlying, enduring trait useful for performing duties. • Excellent professional writing and communication skills. • Excellent organizational and prioritizing capabilities. • Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment. • Excellent interpersonal skills, detailed-oriented and meticulous.
_Education:_ Associate Degree required; Bachelor Degree preferred
_Experience:_ • Clinical and/or scientific experience in a research setting • Management
_Certification or License:_ Research certification (ACRP or CCRP) preferred
We believe our success is dependent on a healthy work environment where our team members are the core of advancing therapies for patients and accelerating drug development. We offer our employees competitive salaries, exceptional benefits including multiple health insurance plan options, a 401K match, employee stock purchase program, career advancement, tuition reimbursement, continuing education, leadership development, an employee discount program, and more. Apply now to learn more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job: *Directors & Managers
Title: Manager of Data Operations for Early Phase Research
Location: Tennessee-Nashville-Sarah Cannon Atrium
Requisition ID: 03058-5480