Clinical
Project Manager
Job ID: 1185
# of Positions Remaining: 1
Location: North Carolina
Category: Research and Development/Clinical
More information about this job:
Overview:
The Clinical Project Manager is responsible for
providing operational support for the delivery of assigned studies or
programs on time and within budget. Primary responsibilities include
coordinating and supervising operational aspects of a clinical study,
providing guidance for other study team members and collaborating with
the Clinical Development team in the overall study management by
monitoring deliverables, schedules, timelines and external team
resources. The Clinical Project Manager contributes to the design and
development of CRFs, Informed Consents, specific protocol sections
(i.e. treatment of subjects and study procedures) and the Data
Management Plan. Other responsibilities include coordinating the
collection of clinical data and the development of study related
documents (monitoring guidelines, source document templates, monitoring
visit report templates and other site tools). The Clinical Project
Manager will also conduct co-monitoring for site evaluations,
initiations, monitoring and closeout visits. The selected candidate
will assume a leadership role to ensure the operational milestones and
timelines are achieved. 20 percent travel is required.
Responsibilities / Qualifications:
We seek a candidate with a BS or BA in a relevant
scientific discipline and a minimum of 5 years direct CRA experience in
the pharmaceutical industry or equivalent. The successful candidate
must have the ability to develop tools and processes that increase
measured efficiencies of the project, experience mentoring and
developing junior staff, excellent interpersonal skills and a
demonstrated ability to lead. Working knowledge and experience with
Word, PowerPoint and Excel is required as well as excellent verbal,
written and presentation skills. Candidates must possess a working
knowledge and understanding of FDA and/or EMEA Regulations, ICH
Guidelines and good clinical practices (GCPs) governing the conduct of
clinical trials.
To apply: http://jobs-salix.icims.com/salix_jobs/jobs/candidate/job.jsp?jobid=1185&mode=apply&apply=yes
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Associate Manager, Clinical
Development, Salix
Pharmaceuticals, NC
Associate
Manager, Clinical Development
Job ID: 1178
# of Positions Remaining: 1
Location: North Carolina
Category: Research and Development/Clinical
More information about this job:
Overview:
The Associate Manager, Clinical Development is
responsible for all day-to-day aspects of clinical trials including
clinical development, vendor selection and management, coordination and
management of data collection, site management and other
responsibilities, as required. The Associate Manager, Clinical
Development oversees the scientific aspects of clinical studies
throughout the duration of the study. The selected candidate provides
leadership and therapeutic expertise for the successful management of
clinical trials and must adhere to strict regulatory requirements of
study conduct and industry standards of Good Clinical Practice. The
Associate Manager prepares study protocols, amendments, specific
sections of study manuals/Investigator meeting notebooks and other
documents as needed. Other primary responsibilities include
contribution to the design and development of CRFs, Data Management
Manuals and Data Analysis Plans as well as preparation and/or review of
data listings, summary tables, study results, manuscripts and
scientific presentations, regulatory documents, IND annual reports, IND
safety reports, Investigator Brochures and NDAs. With direction, the
Associate Manager, Clinical Development also addresses questions
regarding scientific and related procedural issues from Investigators.
Responsibilities / Qualifications:
We seek candidates with an advanced degree and
at
least 5 years of pharmaceutical industry experience or a Bachelor's
degree in a scientific discipline and at least 8 years of
pharmaceutical industry experience (clinic setting experience not
included). Work experience must include at least one of the following:
Protocol/Amendment writing, NDA submission experience, CSR writing,
data listings review and abstract/publications writing. Experience must
include vendor management and multiphase clinical trials (I-III). GI
trial experience is preferred. Excellent verbal and written
communication skills and interpersonal skills are required to maintain
working relationship with team members to ensure scientific integrity
of clinical studies.
To apply: http://jobs-salix.icims.com/salix_jobs/jobs/candidate/job.jsp?jobid=1178&mode=apply&apply=yes
