Openings >> Clinical Project Manager (Remote)
Clinical Project Manager (Remote)
Summary
Title:Clinical Project Manager (Remote)
ID:262001278
Location:Remote - United States
Department:Global Clinical Development
Job Status:Full-time, Benefited
Description
Celerion is looking for a Clinical Project Manager in our Clinical Project Management group to be responsible for the independent operational and financial management and oversight of multi-center and/or external clinical site activities, ensuring compliance to protocol, ICH \GCP, \SOP as well as regulatory and local requirements

This role will be home based anywhere in the United States.  Due to our international footprint, schedule flexibility is important.  This position will travel roughly 30% primarily in the US, but could include Europe on an as needed basis.

 

Essential Responsibilities and Functions:

  • Owns the client relationship with Business Development and is responsible for client communication ensuring high client satisfaction. Pro-active approach to providing solution set for clients in a timely manner.

  • Understand the scope of the contract and any Master Services agreement (MSA) in place for the client.

  • Act as main line of communication between study site personnel and the sponsor.

  • Lead the kick off meetings with client and internal project team, set and agree on milestones, and work with different teams internally and with the client to deliver the study on time and within budget, according to the relevant SOP’s.

  • Lead the initiation, maintenance and close out activities of multi-center and/or external site studies in accordance with the protocol, GCP, and relevant SOPs

  • Pro-actively communicate with the client ensuring the client has all the information required on project progress and status (risk analyses, contingency plans, technical information, significant changes of any kind etc.); provide pro-active decisions /solutions and how the project objectives are being, or should be, achieved.

  • Manage sites efficiently

  • Manage the completion and updates of timelines, tools and project summaries as required

  • Prepare project status reports for management review.

  • Coordinate with Regulatory Affairs and manage the filing of the study required documents in the Trial Master File (TMF)

  • Independently troubleshoot and resolve any issues that may arise.

  • Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial.

  • Provide and support initial and ongoing training to site personnel as needed.

  • Review and training of proper oversight, handling, and accountability of investigational product(s).

  • Collection and management of IRB submissions

  • Verify the accuracy and integrity of study data through collaboration with data management

  • Assist in the processing of SAE information received from investigators including review, clarification and interactions with monitors, sites and sponsor.

  • Management of essential document collection and maintenance, including initial and ongoing approval of the study by a qualified ethics committee (IRB/EC).

  • Oversight of screening and recruitment activities, support site personnel with strategies to ensure enrollment is on target. Maintain enrollment logs regularly.

  • Pro-active identification and mitigation or resolution of issues affecting proper conduct of the trial, including escalation to management and other team members as appropriate to ensure proper resolution.

  • Review monitoring activities in a timely manner in accordance with SOP requirements.

  • Participate in the selection of study sites

  • Manage pre-study, site initiation, routine monitoring, and close out visits with team members as needed.

  • Participate in the review and development of Protocol and CRF.

  • Participate in development of operational plans such as monitoring, data management and safety plans

  • Coordinate and oversee activities with external vendors

  • Oversee the contents and collection of ICH GCP essential documents, and the management of the flow of required documents across sites

  • Determine drug requirements and management of study drug packing, shipping and review of drug labels (as applicable)

  • Manage study drug inventory including ordering, shipping, retest/expiry, destruction/return and tracking.

  • Update and review of clinical trial management tracking systems (CTMS)

  • Run project team meetings and provide appropriate updates and complete accurate and timely meeting minutes

  • Review audit reports and assist in resolution of cited issues.

  • Engage in process improvement activities and building of infrastructure


Knowledge/Skills/Education/Licenses*:

  • Bachelor's degree, preferably in science, nursing, other biomedical discipline, or equivalent. Masters or other advanced degree preferred.
  • Minimum 10 years CRO or Pharmaceutical

  • Minimum of 5 years of direct project management experience in a CRO, Pharma, or Biotech.

  • Minimum of 2+years of experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions

  • This position requires candidates to be detailed-oriented, computer proficient in a Windows environment and possess superior interpersonal and organizational skills

  • Strong public speaking skills

  • Excellent oral and written communication skills

  • Working knowledge of ICH GCP and clinical research regulations

  • Excellent problem-solving and decision making skills

  • PMP is a plus


Company Profile
Celerion is the leading global provider of outsourced clinical research services.  Customers include the leading global pharmaceutical companies as well as biotechnology and small to mid-sized pharmaceutical companies.  Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.  Supporting our clinical work are two world class bioanalytical laboratories located in Europe and the U.S.  Celerion is unique from other leading CROs in that our focus is on early phase clinical studies through clinical proof-of-concept, and beyond.

Services Include:

  • Early Clinical Research and studies required to support product labeling
  • Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD,  medical writing and reporting)
  • Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
  • Drug Development Services (Regulatory affairs and drug development consultancy)
  • Global Clinical Development including project management and monitoring
Celerion is an equal opportunity employer.

EEO/AA M/F/Vet/Disability

 
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