Job Description:
Role: Sr. Clinical Data Management Process Associate
Company: Biopharmaceutical
Location: San Francisco, CA
Duration: Permanent
Role:
Represents the Standards and Training Group within the Biometrics department. Assists in the development and maintenance of Biometrics process documents.
Facilitates the development and refinement of Biometrics standard processes to ensure they are scalable and supports department and cross-functional needs. Biometrics at Sponsor includes Biostatistics, Programming, Bioinformatics, and Clinical Data Management. Reviews, revises and authors procedural documentation including SOPs, Work Instructions, and User Guides by collaborating with subject-matter-experts (SMEs) within and outsides of Biometrics, such as the Clinical Operations, Safety, Regulatory, and Clinical Research groups.
Participates in department or cross functional process improvement initiatives and/or working groups.
Recommends process improvements based on professional and industry experience, regulatory guidelines, professional conferences or via participation in cross-functional and department initiatives.
Develops scalable solutions to complex problems, establishes timelines for project deliverables, and proactively anticipates any risk or concerns that may accompany a proposed solution.
Assist in writing and sending departmental communications regarding process updates.
May helps with development and review of training material.
Requirements:
Effectively communicates ideas, project goals and project statuses during departmental and cross functional process development meetings.
The ideal candidate can influence and negotiate a positive outcome during process development meetings.
Strong background in Clinical Data Management preferred.
Must be an independent thinker and willing to take ownership of tasks while working under limited direction.
Must have strong technical skills in Microsoft Outlook, Word, PowerPoint and Excel.
Experience with EDC Platforms such as Medidata Rave, JMP, Articulate Storyline, and Microsoft SharePoint is desired.
Experience with HTML, CSS, SAS and SQL Programming is a plus. Requires a BS or BA in a relevant disciple or equivalent.
5+ years of experience.
Additional Info:
[Click Here to Access the Original Job Post]
Role: Sr. Clinical Data Management Process Associate
Company: Biopharmaceutical
Location: San Francisco, CA
Duration: Permanent
Role:
Represents the Standards and Training Group within the Biometrics department. Assists in the development and maintenance of Biometrics process documents.
Facilitates the development and refinement of Biometrics standard processes to ensure they are scalable and supports department and cross-functional needs. Biometrics at Sponsor includes Biostatistics, Programming, Bioinformatics, and Clinical Data Management. Reviews, revises and authors procedural documentation including SOPs, Work Instructions, and User Guides by collaborating with subject-matter-experts (SMEs) within and outsides of Biometrics, such as the Clinical Operations, Safety, Regulatory, and Clinical Research groups.
Participates in department or cross functional process improvement initiatives and/or working groups.
Recommends process improvements based on professional and industry experience, regulatory guidelines, professional conferences or via participation in cross-functional and department initiatives.
Develops scalable solutions to complex problems, establishes timelines for project deliverables, and proactively anticipates any risk or concerns that may accompany a proposed solution.
Assist in writing and sending departmental communications regarding process updates.
May helps with development and review of training material.
Requirements:
Effectively communicates ideas, project goals and project statuses during departmental and cross functional process development meetings.
The ideal candidate can influence and negotiate a positive outcome during process development meetings.
Strong background in Clinical Data Management preferred.
Must be an independent thinker and willing to take ownership of tasks while working under limited direction.
Must have strong technical skills in Microsoft Outlook, Word, PowerPoint and Excel.
Experience with EDC Platforms such as Medidata Rave, JMP, Articulate Storyline, and Microsoft SharePoint is desired.
Experience with HTML, CSS, SAS and SQL Programming is a plus. Requires a BS or BA in a relevant disciple or equivalent.
5+ years of experience.
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]