Clinical Data Management _EDC_(JP BP2334) - Alpha Professional Resources, A.P.R., Inc.
Company Description:
Job Description:
Position title:
Clinical Data Management_EDC (JPBP2334) Duration:
Contract12 months (possible ext) Our client, a biotechnology industry.
We are seeking a Clinical Dataprofessionalfor the oncology supportive care group.
Job Details:
Project manage Clinical Data Management (CDM) activities for all studies within a product/therapeutic indication from Protocol review, Study Start:
up to Database Lock and submission/filing.
Responsibilities include:
1.
Oversee a lead data manager working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
2.
Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
3.
Accountability for meeting study/project timelines.
4.
Lead CDM activities for assigned project team.
Communication within their assigned product teams globally and cross:
functionally.
5.
Review of all study related documents within a project area, ensuring consistency and accuracy of content.
6.
CDM representation on assigned project teams e.
g.
Global Clinical Study Team.
7.
Support electronic submission activities.
Critical to have hyperlinking and submission management experience, including experience with publishing software (i.
e.
Adobe Professional) and Inspection Readiness activities in support of filing activities.
Education/Skills:
Bachelor's degree; 5:
6 years' experience in similar role; General leadership and management experience; Study Start Up and Filing/Submission experience a must; related experience in CDM; experience working in an FSP model; use/oversight of EDC systems (RAVE, InForm).
Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
Position title:
Clinical Data Management_EDC (JPBP2334) Duration:
Contract12 months (possible ext) Our client, a biotechnology industry.
We are seeking a Clinical Dataprofessionalfor the oncology supportive care group.
Job Details:
Project manage Clinical Data Management (CDM) activities for all studies within a product/therapeutic indication from Protocol review, Study Start:
up to Database Lock and submission/filing.
Responsibilities include:
1.
Oversee a lead data manager working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
2.
Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
3.
Accountability for meeting study/project timelines.
4.
Lead CDM activities for assigned project team.
Communication within their assigned product teams globally and cross:
functionally.
5.
Review of all study related documents within a project area, ensuring consistency and accuracy of content.
6.
CDM representation on assigned project teams e.
g.
Global Clinical Study Team.
7.
Support electronic submission activities.
Critical to have hyperlinking and submission management experience, including experience with publishing software (i.
e.
Adobe Professional) and Inspection Readiness activities in support of filing activities.
Education/Skills:
Bachelor's degree; 5:
6 years' experience in similar role; General leadership and management experience; Study Start Up and Filing/Submission experience a must; related experience in CDM; experience working in an FSP model; use/oversight of EDC systems (RAVE, InForm).
Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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