Senior Director of Research Teams – Data Management Specialist

Posting Number: #025-21

Position Title: Senior Director of Research Teams- Data Management Specialist

Closing Date: Until Filled

Location: Monrovia, CA

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Program Summary

Children’s Oncology Group (COG), a project of PHI, is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.

Essential Duties & Responsibilities

Maintain and coordinate the necessary infrastructure to develop, implement and conduct clinical trial activities as well as collect clinical trial data in accordance with relevant GCP guidelines including:

  • Oversight of the recruitment, orientation and continuing staff development for employees assigned to the teams
  • Supervision and mentorship of team members
  • Ensure cross-training of team members and plan for coverage of functions in the event of staff turnover, illness or surges in the workflow.
  • Ensure development, maintenance and implementation of Standard Operating Procedures, as required
  • Interface with other relevant groups/leaders as appropriate, including:
    • Faculty statisticians
    • Disease, discipline and domain committees
    • National Cancer Institute, Cancer Therapy Evaluation Program
    • Regulatory Oversight Committees
    • Other COG core services
    • Industry liaison

Manage clinical trial planning and implementation activities.

  • Monitor the development of all clinical trials assigned to any of the teams within her/his scope.
    • Coordinate with appropriate study committee members and COG core resources to assure timely development and implementation of clinical trials.
    • Assist team members with identifying solutions to barriers to study development or implementation.
  • Assure that all regulatory documentation is complete for all clinical trials.
  • Review all study-specific communications to COG membership.
  • In coordination with the COG Industry-Sponsored Trials Director, serve as a key contact for industry sponsors during the planning and conduct of the trial.
  • Develop quality assurance plans, targets and metrics for teams (e.g. accuracy, timeliness, reliability, productivity). Regularly review and measure progress against goals. Proactively address challenges.
  • Working with others, engage in process improvement activities to actively continuously improve the quality and timeliness of clinical trial activities

Coordinate the training and continuing education of Research Coordinators across teams.

  • S/he will lead the establishment and maintenance of data management practices, guidelines and policies for COG, with input from the Group Statistician, Chief Operating Officer, and other Senior Directors of Research Teams.
  • Represent the COG in meetings and teleconferences within the National Cancer Institute’s National Clinical Trials Network (NCTN).
  • Develop, in consultation with the Group Statistician, Chief Operating Officer, and other Senior Directors of Research Team, standard operating procedures that govern new study case report form (CRF) development in Medidata Rave as well as the conduct and data management of existing studies in legacy data systems and in Medidata Rave.
  • Author sections of grant applications addressing data operations and management and develop/justify budgets that meet the needs of the COG.

Develop a positive and proactive team culture and foster effective relationships with other COG leaders, staff, COG Members and their institutions.

  • Develop and maintain collaborative relationships and approaches with COG leadership.
  • Work collaboratively with COG leadership to develop COG as a high functioning team-based environment. Maintain professional and effective communications and proactively resolve challenges.
  • Coordinate with other COG Directors and Managers to derive and implement COG-wide process improvement initiatives.
  • Build a culture of trust and teamwork among teams and team members.
  • Encourage communication and proactive problem-solving.
  • Develop and encourage positive relationships and communications with COG stakeholders.
  • Lead through example, upholding the mission and purpose of COG

Perform administrative tasks and participate in other COG activities as required, including but not limited to:

  • COG educational and training activities
  • Study-specific budget development and preparation, implementation, and analyses, as required
  • Oversee development and compilation of accrual and other reports for site reimbursement.
  • Meeting planning and coordination.

Minimum Qualifications

  • Graduate degree and at least 5 years related experience or Bachelor’s degree and at least 7 years experience related experience.
  • 5-10 years of data operations/clinical trials experience
  • Excellent interpersonal skills and demonstrated ability to supervise and manage staff.
  • Proven experience in managing multiple projects within a network environment.
  • Excellent written and oral communication skills.
  • Must be familiar with essential FDA regulations governing clinical trials
  • Goal/results-oriented with a proactive approach to problem-solving.

Desired Qualifications

  • Experience in electronic data capture (EDC), database design, development and implementation.
  • Experience in clinical data management in a comprehensive cancer center, a cooperative group or the pharmaceutical/biotechnology industry.
  • Experience with Medidata Rave or a similar clinical trial management system.
  • Certification as a Clinical Data Manager, Medidata RAVE, CCDM or other reputable industry certification for clinical data management.
  • Knowledge of oncology research.

Important Information

  • This is a full-time (40 hours/week) position.
  • To qualify for this position, applicants must be legally authorized to work in the United States.

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

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