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Clinical Project Manager

Company:
Artech Information Systems
Location:
Gaithersburg, Maryland, United States
Posted:
November 12, 2018

Description:

Job Description:

Job Title: Clinical Project Manager

Job ID: AZNJP00008105

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