Returning Candidate?

Manager, SCHARP Clinical Data Management

Manager, SCHARP Clinical Data Management

Job ID 
10920
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Clinical Research Support Services

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD), works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Join us and make a difference! Careers Start Here.

 

The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center in Seattle, WA is seeking a highly motivated and effective manager for oversight and leadership of the day-to-day technical and functional performance of assigned Clinical Data Management staff. The Manager of the Clinical Data Management team will report to senior leadership at SCHARP.  

 

Job Summary

The Manager of Clinical Data Management (CDM) provides operational and technical leadership and guidance to the team, and serves as an expert for problem-solving data management issues. The Manager, CDM collaborates with other SCHARP managers and leaders to help implement workgroup and organizational initiatives and strategy. This includes developing policies and procedures; implementing continuous quality improvement activities; and managing workflows, resources and prioritization. The Manager is responsible for overseeing a team of CDMs that project manage and coordinate the implementation of assigned phase 1 to 3 clinical trials and monitor the collection, processing, and quality control of trial data.

Responsibilities

The Manager, CDM is responsible for the direct supervision of Clinical Data Management staff and uses independent judgment for all personnel issues including hiring, training, evaluation, discipline, and, as required, termination of staff.  The Manager works independently in performing both routine and non-routine tasks and uses best judgment in making decisions regarding all data management, quality control, study materials, and liaison tasks.  

 

The Manager, CDM is responsible for effectively overseeing timelines, quality assurance and delivery of data for clinical trial protocols, coordinating data management projects, and collaborating with external customers and other groups within SCHARP. The Manager is responsible for coordinating activities of the data management staff, assigning tasks, developing and maintain project timelines, monitoring progress of data management activities and creating plan documentation. S/he communicates study status, timeline updates, scope change with internal project management, team resources and departmental leadership, and escalates project and departmental issues as needed. The Manger will identify and implement process improvements of SCHARP procedures and practices; help develop and maintain the standardization tools and training materials; optimize interdisciplinary teamwork across functions to drive effective and efficient Clinical Data Management practices; and develop and maintain strong working relationships and effective communication with SCHARP leadership and with functional peers.

Qualifications

Minimum Qualifications: 

  • Bachelor’s Degree in Life Science, Nursing, Computer Science or related disciplines or equivalent combination of experience and education
  • 8+ years of experience in CDM, of which 5 years in either a leadership role as a Team Leader/Manager for a significant clinical program, or a supervisorial role within a CDM function in a pharmaceutical, CRO, biotech or life sciences research organization.
  • Demonstrated CDM leadership and collaboration skills across functions to drive effective and efficient Clinical Data Management practices.
  • Excellent project management and organizational leadership experience.
  • Proficiency in the development and use of commercial clinical data management systems/EDC products
  • Working knowledge of FDA & ICH, GCP, GCDMP, and related clinical research regulatory requirements

Preferred Qualifications:

  • Graduate Degree in Life Science, Nursing, Computer Science or related disciplines
  • 10+ years of experience in CDM, with at least 5 years’ management experience in a pharmaceutical, CRO, biotech or life sciences research organizations.
  • Advanced knowledge of regulatory and clinical research business requirements

 

About Us:

The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center provides statistical collaboration to infectious disease researchers around the world. SCHARP collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of HIV and other diseases as a threat to human health. SCHARP currently provides statistical and data management services to the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Microbicides Trials Network (MTN), and the Collaboration for AIDS Vaccine Discovery (CAVD).

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.