Specific responsibilities include:
– Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects;
Manage CDM activities including Medical Coding, Data Validation Checks, and Database Snapshot;
Manage communication with eCRF/database vendors on consistent basis to address clinical team requests and/or eCRF development activities;
Provide Clinical Data Management support to cross-functional team;
Participate in the review of Clinical Research documents (Protocols and CRS) as needed;
Manage and participate in UAT of eCRF build and validation documents, included but not limited to edit check document, issue logs and UAT summary report;
Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards;
Manage Study Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment;
Manage and participate in study-specific meetings, teleconferences and training;
Collaborate with cross-functional team members and study sites throughout all studies; and
Lead one or more studies at a client.
Requirements:
Associate’s degree in computer science, statistics, or equivalent a plus; ? 5 years’ experience with one or more of the leading CDM software applications, e.g., Oracle Clinical, InForm, etc. is required;
8 plus years Pharmaceutical or CRO industry experience desired;
Minimum 1 year of project lead/project management experience managing projects and/or staff;
Supervisory experience;
Experience and knowledge of the drug development process desired;
Good interpersonal and communication skills;
Experience in a clinical development environment;
Proven communication skills;
Self-starter who is able to work independently and willing to provide original thinking;
Successful team player with good oral and written communication skills; and
Candidates must be fluent in English language (both verbal and written).
* CO candidates may not be considered.
The Planet Group
Deerfield Illinois
United States
Healthcare - Physician
(No Timezone Provided)
Specific responsibilities include:
– Develops/executes/reviews project documentation including but not limited to, data management plan, eCRF Completion Guidelines, Edit Check, Query Logic, UAT, and work instructions for assigned projects;
Manage CDM activities including Medical Coding, Data Validation Checks, and Database Snapshot;
Manage communication with eCRF/database vendors on consistent basis to address clinical team requests and/or eCRF development activities;
Provide Clinical Data Management support to cross-functional team;
Participate in the review of Clinical Research documents (Protocols and CRS) as needed;
Manage and participate in UAT of eCRF build and validation documents, included but not limited to edit check document, issue logs and UAT summary report;
Ensure the quality of clinical data to support study report, IND and NDA submissions meets standards;
Manage Study Start-Up: work across several studies to ensure all required documentation is in place in order to authorize sites for study enrollment;
Manage and participate in study-specific meetings, teleconferences and training;
Collaborate with cross-functional team members and study sites throughout all studies; and
Lead one or more studies at a client.
Requirements:
Associate’s degree in computer science, statistics, or equivalent a plus; ? 5 years’ experience with one or more of the leading CDM software applications, e.g., Oracle Clinical, InForm, etc. is required;
8 plus years Pharmaceutical or CRO industry experience desired;
Minimum 1 year of project lead/project management experience managing projects and/or staff;
Supervisory experience;
Experience and knowledge of the drug development process desired;
Good interpersonal and communication skills;
Experience in a clinical development environment;
Proven communication skills;
Self-starter who is able to work independently and willing to provide original thinking;
Successful team player with good oral and written communication skills; and
Candidates must be fluent in English language (both verbal and written).
* CO candidates may not be considered.