Manager, Clinical Data Management is responsible
for all data acquisition and management activities
within the business unit. Supports the Biometrics
and Clinical Development groups in promoting the smooth and efficient functioning of clinical research operations. Responsible for defining data
management processes and standardization.

Responsibilities:

Forecast staff needs based on project load
and internal capacities.

Estimate data management costs to provide input
to the budget.

Communicate key milestones and project plan
to data management staff.

Ensure timely and accurate completion of all
data management activities.

Develop departmental strategies for data acquisition, processing and review.

Communicate progress to the project/study teams
on an ongoing basis.

Participate in protocol development and ensure
trial planning incorporates global standards
and database functionality.

Provide leadership to those designing CRFs and
ensure compliance with standards.

Provide expertise to the study teams for the development of data validation checks.

Oversee the conduct and compilation of data
validation checks, review results and
provide decision making.

Respond to internal and external inquiries during
the database development process.

Ensure consistency and appropriateness of data collection across studies.

Communicate progress to the project/study teams
on an ongoing basis.

Clearly identifies and documents needs and
expectations as it pertains to the project.

Evaluate data management vendors with regard
to systems, processes and SOPs.

Participates in negotiations with contractors and
vendors for data management activities.

Establish a communication plan to track ongoing
project status, milestones and deliverables, to
ensure appropriate outcomes and results.

Negotiate the assignment of responsibility and
resources with other functional areas to meet
corporate and project goals.

Continually evaluate systems, processes and
technology used by data management and clinical development, and keep abreast of those used
in the industry.

Ensure proper and timely training to optimize the introduction and implementation of new workflow processes and technology.

Implement processes that ensure consistent efficient
and accurate data collection that meet the needs
of the study protocol.

Initiate discussions and recommendations relative
to potential use of new systems/processes that
would enhance the Data Management function.

Actively participate in the generation and review of global documents (SOPs, working procedures, etc.)
for data management and clinical operations.

Review SAS safety tables/listings for accuracy
and consistency.

Coordinate retrieval and manipulation of data from external sources for inclusion into final data directory.

Develop staff, maximizing skills and capabilities as
well as developing the group as a cohesive team.

Provide mentoring in areas of expertise.

Requirements

Bachelors degree in related field required.

Four to seven years experience performing data management for clinical trials and two to three years experience supervising data managers required.

Experience with PL/SQL in a data management environment.

Experience with Clintrial or similar data management front-end to Oracle RDBMS.

Knowledge of database and CRF design.

Experience in dealing with external sources of data,
i.e., CROs, central labs, etc.

If applicable, two to three years experience with SAS
as a reporting tool, i.e., generating tables and listings

Competencies: Interpersonal savvy, Teamwork,
Project Management, Negotiation/conflict management, directing others, Planning, Setting priorities