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Position Title:
ASSISTANT DIRECTOR (DATA MANAGEMENT)/WARM BASE
Position Number:
003A
Project Worksite:
Central Office/AMD (1 position)
Deadline for submission: Friday, October 13, 2023, at 5:00pm Liberia Time
About PREVAIL:
PREVAIL, or the Partnership for Research on Vaccines and Infectious Diseases in Liberia, is a clinical research partnership between the U.S. Department of Health and Human Services and the Liberian Ministry of Health
Summary of Position:
Under the overall guidance and direction of the Network Director, the Assistant Director of Data Management will provide strategic guidance, direction, and oversight on the overall data management activities of the PREVAIL initiative. The position will represent the program on the Operations Management Team and will liaise with other colleagues to successfully deliver operational excellence to clinical operations and data management planning for clinical trials. The Assistant Director of Data Management will support the Network Director and Deputy Directors of Clinical Operations and Administration in the effectiveness of operational service delivery. The position will also support the effectiveness of clinical trial operations; and creative responses to emerging complex challenges. The Assistant Director will be responsible for supervision and guidance of oversight for Data Management and ensuring collaboration and coordination across units and departments. S/he will ensure trials have a results-oriented approach and consistency with standard clinical operations procedures and good science management practice. Essential functions include, but are not limited to, the following:
Description of Responsibilities
 Leads statistical design and analytical efforts for clinical research studies.
 Conducts advanced statistical analysis, including regression, survival analysis for Clinical trials and Observational studies.
 Collaborates with Principal Investigator to define research questions and hypotheses, design research protocols.
 Determines appropriate sample size, randomization procedures, and statistical methods for research protocols.
 Develops and implements data management strategies, and standard operating procedures in alignment with research objectives.
 Collaborates with senior management to set data management priorities and long-term vision.
 Provides leadership, mentoring, and professional development opportunities to members of the team.
 Sets performance goals, conducts performance evaluations, and manages staffing needs.
 Oversees all data management activities, including database design, data entry, data cleaning, and validation. Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL) Liberia – U.S. Joint Clinical Research Partnership The Mitchell Group, Inc. (TMG)
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 Ensures data management processes adhere to regulatory requirements, international standards, and best practices.
 Collaborates with database developers and administrators to design and maintain clinical research databases.
 Establishes and enforces data security protocols to prevent participant confidentiality and ensures compliance with privacy regulations.
 Ensures that data is readily available and accessible for research purposes and reporting to regulatory authorities.
 Ensures that data management and biostatics practices comply with relevant regulatory requirements, including Good Clinical Practice and 21 CFR Part 11.
 Assists with regulatory submission and participate in audits as necessary.
 Assists in the development of data management budget and costing of Clinical research protocol.
 Stays informed about emerging technologies and best practices in data center management, data storage and retrieval.
 Monitors clinical research quality and timeliness of protocol implementation.
 Provides guidance and oversight to direct report(s) including the management of workload, special projects, performance reviews and management, and career development.
 Ensures all clinical and science operations at all sites are carried out, effectively, efficiently, on time and in a transparent manner.
 Other duties as assigned.
Skills:
 Excellent management and leadership skills with the ability to build strong relationships with clients, focus on impact and result, and responds positively to feedback.
 Extensive experience in Clinical data management and biostatistics, with a proven track record of progressively responsible roles.
 Strong understanding of data management systems, database design and data standards
 Expertise in statistical methodologies, statistical software (e.g. SAS, R, Stata), and data analysis techniques
 Excellent communication, problem-solving, and decision-making skills.
 Detail-oriented with a commitment to data accuracy, integrity, and quality
Leadership Competencies:
 Commitment to the Organization, its Mission, and Values
 Cultural Sensitivity/Valuing Diversity
 Building and Managing Relationships/Encourages Collaboration
 Performance Management/Promotes Staff Accountability
 Conflict Management/Coaching and Mentoring
 Results Orientation/Commitment to Excellence
 Knowledge Sharing/Continuous Learning
Qualifications
 Education: Master’s degree in Biostatistics, Data management, Bio Informatics, or other related fields.
 Preferred Job-related Experience: At least six (6) years of relevant experience of development in a governmental, multilateral, or civil society organization in a multi-cultural setting, including three (3) or more years of senior-level management responsibilities.
 Additional Eligibility Qualifications: Minimum of five (5) years’ experience managing staff in multiple levels of an organization, both management and individual contributor level staff.
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Application Instructions:
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