Previous Job
Previous
Clinical Project Manager
Ref No.: 18-52154
Location: Gaithersburg, Maryland
Start Date / End Date: 10/29/2018 to 10/28/2019
Job Description:
Job Title: Clinical Project Manager
Job ID: 18-52154
Location:
Gaithersburg, MD
Duration: 12 Months
Job Summary

Plan and manage overall clinical operations for assigned clinical trials)/projects including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. Provide matrix management of functional area representatives to cross-functional clinical trial teams (CTTs). 

Major Duties and Responsibilities: 

·         Convene and lead cross-functional clinical trial teams (one or more) 
·         Define and manage accountabilities for all clinical trial team members 
·         Collaborate with AD/D, Clinical Operations to ensure proper resourcing for assigned trials 
·         Contribute to the Clinical Study Protocol (CSP) and may contribute to the Protocol Concept Sheet(PCS) 
·         Develop outsourcing specifications for vendor requests for proposal and scope of work agreements 
·         Participate in and guide study team in vendor selection 
·         Manage the vendor(s) throughout the life of assigned clinical trial(s) 
·         Select investigational sites with input from Clinical Development and vendors 
·         Review, refine, and approve Clinical Operations Plans including study monitoring and other plans 
·         Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization (CRO) Team members including Clinical Research Associates (CRAs) 
·         Lead ongoing review of data to ensure quality and consistency 
·         Plan and conduct investigator meetings and can support advisory board planning and conduct ad boards 
·         Develop and manage study budget and may develop and manage program budgets 
·         Oversee site agreement/budget negotiation process 
·         Develop and manage study timelines (including recruitment) and may develop and manage program timelines 
·         Manage and lead CTT risk &opportunity management 
·         Oversee the submission of trial-related and essential documents to the Trial Master File 
·         Identify and provide solutions to clinical trial issues 
·         Provide input into non-project related activities and development of procedures as requested 
·         Mentor staff and serve as a resource for new employees 
·         May serve as a line manager of Project Coordinators 
·         Provide or facilitate training to clinical study teams on protocol specific topics 
·         Participate as appropriate in internal and external audits 
Requirements/Qualifications: 
Education

University degree, preferably in a biologic/scientific discipline 
Experience

·         Minimum of 5 years progressive experience in clinical operations including project coordination, site management and monitoring or equivalent and at least 3 years of project management experience or equivalent. 
·         For Sr. CPM: a minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent.
Special Skills/Abilities: 
·         Thorough understanding of country level regulations, ICH and GCP guidelines 
·         Thorough understanding of cross-functional clinical processes including data management, 
biostatistics, medical writing, drug safety, and regulatory affairs 

·         Ability and willingness to travel 25% of the time (internationally and domestically) 
Job Complexity: 
·         Provide technical solutions to a range of difficult problems 
·         Ability to manage early stage clinical trials and potentially large/global clinical trials with low to moderate complexity
Supervision
Work under a moderate level of oversight of Sr CPM or AD/D Clinical Operations 



Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 973.967.3540
 
Thanks,
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email:nisha.samuel@artechinfo.com| Website:
www.artech.com
Artech is the #1 Largest Women-Owned IT Staffing Company in the US!

Connect with us on - LinkedIn | Facebook | Twitter