Social
& Scientific Systems is seeking a Data Manager to manage and provide a
range of clinical research support activities for the Indonesia Research
Partnership on Infectious Disease (INA-RESPOND) and South East Asia Infectious
Disease Clinical Research Network (SEAICRN) Operations Center in Jakarta,
Indonesia (managed by Social and Scientific Systems, Inc (SSS). Duties
include but are not limited to: responsible for data management function;
provide clinical research site training and support for protocol implementation
and site development activities; conduct site visits; conduct quality
management activities, manage work with other members of the operations center
to ensure that all protocol related activities are completed according to
client timelines; provide support to the protocol development team; conduct
review of protocol documents; assist with development of project budgets; serve
as a data manager. Candidate must be comfortable working in a fast-paced
environment and must be fluent in Bahasa Indonesia and English.
Duties and Responsibilities
Key duties and responsibilities may
include, but are not limited to, the following:
Data Management: Responsible for Case Report Form
(CRF) design, development, and maintenance. Coordinate, prepare, and provide
training of all key data management related study documents including CRF
completion instructions, Data Management Guidelines, CRF Annotation, Data Entry
Guidelines. Coordinate data entry screen testing, edit check programming and
testing. Develop, generate and manage data queries, reports, and other data
related activities. Provide support to clinical site staff regarding queries of
data management system, develop site training materials and conduct training
sessions. Plan and implement QC steps, such as checking tables, verifying data
entry, and reconciling text and tables. figures, and listings,
Site Liaison: Serve as the liaison between SSS and the investigators and
staff of Indonesian clinical research sites, regarding protocol implementation
and site activation activities. Track and report site progress, work closely
with site staff to resolve issues impacting site performance, and serve as a
primary point of contact for sites needing information, advice, or other
technical assistance. The project’s critical communications processes will be
managed through site visits, e-mail, conference calls, face-to-face meetings,
and maintenance of a web-based portal.
Site Assessment and Preparedness Evaluation: Manage all activities that
support site preparedness for protocol activation, implementation, and
closeout. Participate in visits to clinical research sites to assess the
infrastructure, resources, and training capabilities needed to conduct
Indonesian and SEAICRN clinical trials. Prepare reports on findings and
recommendations. Coordinate development, management and implementation of
quality assurance strategies and initiatives.
Training Coordination: Organize, schedule and coordinate clinical
research site staff training and educational efforts in areas such as:
administration, site establishment, regulatory affairs, site operations and
record keeping, clinical research, and good clinical practice (GCP). Coordinate
logistics for site visits, meetings, and trainings of clinical research site
staff. Participate in development of training and educational materials and
general training curricula suitable to specific study and site needs.
Protocol Development and Implementation: Manage activities associated
with protocol development and implementation including coordinating and
providing guidance and support to protocol teams. Set up call/meeting schedules,
create call/meeting agendas in consultation with the client, run
calls/meetings, provide call/meeting summaries, manage timelines, and otherwise
collaborate with team members in order to meet objectives. Coordinate the
writing of and edit and disseminate the protocol. Draft protocol-related
documents such as informed consent forms, manuals of operations, and other
documents as needed. Contribute to the creation and review of CRFs and the
development of site budgets.
Regulatory: Maintain current regulatory knowledge and keep abreast of
regulatory procedures and changes. Coordinate development/maintenance of
site/country specific regulatory profiles. Liaise with government and
regulatory representatives as needed. Oversee the regulatory document and requirements
review and tracking process. Review and ensure that site-specific informed
consent forms, 1572/Investigator Agreement forms, and other documents are in
compliance with regulatory requirements. Provide mentoring, guidance, and
training to site staff to help ensure compliance.
Conflict and Problem Resolution: Anticipate and identify potential
problems and propose preventive measures and solutions. Identify and implement
measures to facilitate process improvement.
Site remedial activities: Manage and coordinate any needed site
assistance required for remedial or corrective action required as a result of
monitoring/auditing by regulatory agencies or entities. Participate as required
in site assessment/site initiation visits.
Coordination with SSS staff, Indonesian Network members, SEAICRN members,
Consultants, and Other Contractors and Regulatory Agencies: Serve as a
representative of the project and SSS, communicating professionally and
effectively with the client and all collaborators. Provide mentoring and
training to other Operations Center staff, and collaborate closely with staff
in other SSS country offices.
Required Skills
· Competently manage a very heavy
workload, and multiple projects with competing priorities, switching priorities
quickly as needs change. Must be comfortable working in quick-paced
environment.
· Demonstrate a very high level of
technical skill and expertise as pertains to clinical research site support and
development.
· Experience working within a clinical
data management system
· Demonstrate high proficiency in
project planning and organization and proactively anticipate and identify
complex issues and problems.
· Demonstrate experience in
preparation and management of budgets
· Demonstrate exceptional
interpersonal skills and written and verbal communication abilities.
· Demonstrate excellent
decision-making abilities with competency in making decisions and resolving
problems that could have an impact on the Project and/or SSS.
· Recognize which decisions may have a
consequential effect on the Project and/or SSS and make decisions based on
experience, skill, and situation, consulting with and/or informing others as
appropriate.
· Act as the spokesperson for the
Project/SSS and consider the implications of input/decisions, ensuring they are
communicated appropriately.
Required Experience
· A baccalaureate degree from an
accredited college or university. A master’s or doctorate level degree or
equivalent is preferred.
· Relevant experience or coursework in
public health, biomedical research or other related field.
· A minimum of 5 years of increasingly
responsible, broad and diversified professional management experience relevant
to implementing clinical trials, research, or biomedical training programs.
· The ability to competently and
independently manage all of the above Duties and Responsibilities with minimal
guidance and supervision.
· Fluent in Bahasa Indonesia and
English languages, both written and spoken.
· Previous experience working with
US-government funded clinical research projects strongly preferred.
To apply,
please email your Resume/CV to Meity Siahaan, Finance and Admin Manager at MSiahaan@s-3.com
Please write down the position that you'd like to apply in the subject line of
your email.
Interested parties should respond immediately.
Application
closing date: October 7, 2012.
Only
shortlisted candidates will be contacted.
No phone
and e-mail inquiries, please.
More information about Social & Scientific Systems, Inc can be found on our
website http://www.s-3.com/
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