Clinical Trials Data Operations Lead

Summary:

Under supervision of the Brown Health Office of Cancer Research Operations Manager and in accordance with established departmental policies and procedures, the Clinical Trials Data Operations Lead is fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, this individual is expected to provide guidance and mentorship to staff regarding department/trial operations, interact with senior level study management personnel within and outside of Brown University Health, and complete work in a resourceful, self-sufficient manner.

Responsibilities:

Ensures that research is conducted in accordance with the approved protocol, Good Clinical Practice, and guidance established by the Brown University Health Research Protections Office (RPO).

Participates in interview, selection and evaluation of other research staff.

Lead and mentor Operations - Data Management team members responsible for cancer research data management and ensure data operations align with departmental/industry standards.

Manage data operations timelines, milestones, and resources to ensure that data entry, queries and other job functions are completed on time.

Maintain oversight of the day-to-day operations of assigned projects.

Fulfill the role as lead trainer and provide training and guidance to Operations - Data Management team members on best practices, tools, and systems used in clinical trials data management. Promote a culture of continuous improvement and knowledge sharing.

Prepare and maintain departmental training materials.

Contribute to identification and implementation of process improvement opportunities.

In partnership with department leadership, identify additional needs for development of departmental methods or procedures and act accordingly. Provide edits/revisions to departmental policies and procedures, as necessary

Collaborate with investigators and management on project feasibility and implementation of proposed projects through assessment of logistical requirements based on current research environment. Troubleshoot and develop new capacities as needed for innovative clinical trial requirements.

Work cross-functionally and collaborate with internal and external departments.

Address any issues or obstacles that arise during data collection and entry.

Resolves problems and monitors reports from sponsors.

Promote the role and relationship of the Brown University Health Clinical Research Center across Brown University Health department affiliates and with study sponsors through participation in meetings, symposiums, and presentations by acting as a representative of BHOCR.

Assist and support Operations - Data Management team members as needed.

Perform other tasks and responsibilities as directed. 

Other information:

EDUCATION:

Completion of a bachelor's degree in relevant field

EXPERIENCE:

Strong understanding of clinical research workflow and protocol comprehension.

Familiarity with data management systems and data integration tools.

Excellent written and verbal communication skills.

Exceptional attention to detail, problem solving and organizational skills

Ability to work independently and cross-functionally to manage multiple projects and meet deadlines.

Perform duties in a hybrid environment with appropriate telework agreement established.

2-5 experience in cancer clinical research experience.

Proven ability to lead, manage and motivate a team.

Data Management experience preferred.

SUPERVISORY RESPONSIBILITY:

Provides functional guidance to others who may be assigned on a project basis.

Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor.

Location: Rhode Island Hospital, USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union