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Clinical Trials Manager - III

Job Description

Hi,


My name is Rohit  I’m a Recruiter with ACS Group, a leading information technology services and workforce solutions company, and I’m contacting you about an opportunity with one of our clients. ACS works closely with Fortune 1000 firms throughout the US and provides top talent for various staffing needs across industries.



Please review the Job Description provided below and if interested, please call me at 770-255-7921 OR reply to this email



Kindly send your current and updated CV in MS Word Format for evaluation, scrutiny, assessment and possible consideration


 


Below are the Details of Opportunity


-----------------------------------------------------


Duration:12+ Months


Location: Foster city,CA


Requisition Title: Clinical Trials Manager - III

Job Requirements

Summary:




Must meet all requirements for Clinical Trials Manager and have demonstrated proficiency in all relevant areas. In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Coaches members of a work team and ensures adherence to established guidelines.Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials. Anticipates obstacles and client difficulties and implements solutions to achieve project goals. Assists CPM in revising project timelines/budgets as necessary. Works with management on departmental issues, providing input to clinical operations strategies and work plans.Communicates with functional peers regarding project status and issues and ensure project team goals are met. Contributes to development of abstracts, presentations and manuscripts.Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.Participate in training of CPAs and CRAs. Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements. Travel is required.Excellent interpersonal skills and demonstrated ability to lead is required. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. Strong communication and influence skills and ability to create a clear sense of direction is necessary. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience in developing RFPs and selection and management of CROs/vendors. Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision. Ability to examine functional issues from a broader organizational perspective. Functional expertise to initiate, author, or contribute to SOP development, implementation, and training

Job Snapshot

Location US-CA-Foster City
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Pharmaceutical, Health Care, Biotech
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Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-CA-Foster City
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Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-CA-Foster City
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Pharmaceutical, Health Care, Biotech
Store Type:

Job Description

Hi,


My name is Rohit  I’m a Recruiter with ACS Group, a leading information technology services and workforce solutions company, and I’m contacting you about an opportunity with one of our clients. ACS works closely with Fortune 1000 firms throughout the US and provides top talent for various staffing needs across industries.



Please review the Job Description provided below and if interested, please call me at 770-255-7921 OR reply to this email



Kindly send your current and updated CV in MS Word Format for evaluation, scrutiny, assessment and possible consideration


 


Below are the Details of Opportunity


-----------------------------------------------------


Duration:12+ Months


Location: Foster city,CA


Requisition Title: Clinical Trials Manager - III

Job Requirements

Summary:




Must meet all requirements for Clinical Trials Manager and have demonstrated proficiency in all relevant areas. In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Coaches members of a work team and ensures adherence to established guidelines.Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials. Anticipates obstacles and client difficulties and implements solutions to achieve project goals. Assists CPM in revising project timelines/budgets as necessary. Works with management on departmental issues, providing input to clinical operations strategies and work plans.Communicates with functional peers regarding project status and issues and ensure project team goals are met. Contributes to development of abstracts, presentations and manuscripts.Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.Participate in training of CPAs and CRAs. Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements. Travel is required.Excellent interpersonal skills and demonstrated ability to lead is required. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. Strong communication and influence skills and ability to create a clear sense of direction is necessary. Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction. Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience in developing RFPs and selection and management of CROs/vendors. Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision. Ability to examine functional issues from a broader organizational perspective. Functional expertise to initiate, author, or contribute to SOP development, implementation, and training

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Clinical Trials Manager - III Apply now