Associate Clinical Trial Manager job in Redwood City, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: CRA Manager, Project/Study Manager (CSM/CPM), Clinical Scientist

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for an Associate Clinical Trial Manager with a pharmaceutical company located in Redwood City, CA. A success candidate will have experience with clinical operations and vendor management. A bachelor's degree is a must.

Job Responsibilities:

Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
May contribute to SOP development.
Provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required.
May resolve routine monitoring issues.
Must be familiar with good documentation practices and electronic trial master file system.
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
Participate or effectively run meetings and conference calls with CROs, vendors, and multi-functional teams.
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
Must have a general understanding of functional issues and routine project goals from an organizational perspective.
May participate in abstract presentations, oral presentations and manuscript development.
Interface with individuals in other functional areas to address routine study issues.
Ability to develop tools and processes that increase measured efficiencies of the project.
May be asked to assist in the training of CTMAs and CPAs.
Assist in CRO or vendor selection.
Coordinate CROs or vendors.
Assist in the setting and updating of study timelines.
May participate in departmental or interdepartmental strategic initiatives under general supervision.
Assist in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required.
Assure site compliance with the protocol and regulatory requirements.
Draft and coordinate review of protocols, informed consents, case report forms and monitoring plans

Skills and Requirements:

Excellent verbal, written, interpersonal and presentation skills are required.
Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Working knowledge and experience with Word, PowerPoint and Excel.
Experience in Clinical Operations and a degree in a relevant scientific/medical discipline.
Must be familiar with routine medical/scientific terminology.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-CN1