Project Manager - Clinical Bethesda,  MD Current Openings | Xenia Systems
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Project Manager - Clinical

Job Title
Project Manager - Clinical
Job ID
27057581
Location
Bethesda,  MD 20892
Other Location
Description

Xenia Systems is seeking a Project Manager experienced with the Oncology community in the oversight of coordinating the facilitation of clinical trial data collection. The Clinical Project Manager is responsible for providing customer-focused leadership and project oversight. This position facilitates communication among (but not limited to) Xenia team members, clinical trial reviewers, client stakeholders, and client staff.

The Clinical Project Manager proactively solves issues, and oversees the successful implementation and monitoring of clinical studies to ensure that data collection from DCP Databases and related applications are accurate, clean, and complete. It is imperative that the incumbent have clinical project/program management experience supporting clinical trial data gathering and information management.

RESPONSIBILITIES:

Under the supervision of the Division of Cancer Prevention (DCP) and responsibilities relative to the management of Clinical Trial data will include, but will not be limited to:

  • Manage and coordinate the activities and data of clinical trials with the Xenia Team.
  • Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
  • Develop study timelines based on protocols and standard operating procedures (SOP).
  • Modify existing or create new SOPs for (but not limited to) document processing, data abstraction, and file maintenance.
  • Serve as subject matter expert in reducing administrative burden of trial development on National Cancer Institute (NCI) staff by providing recommendations and comments to the DCP COR and DCP informatics support contractors.
  • Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely Contracting Officers Representative (COR) approvals for clinical trials activities.
  • Monitor and ensure that project scope, milestones, and deliverables are fulfilled within timelines.
  • Support and coordinate with the client personnel to ensure completion of the Clinical Trial reports, as applicable.
  • Monitor hours of contract and budget.
  • Review and approve purchases within the scope of the contract and overall personnel management.
  • Regularly interact with management, Xenia team members on matters concerning project milestones, regulatory issues, and other relevant issues.
  • Develop educational programs related to client function.
  • Maintaining systems and files for tracking administrative information and documents related to clinical trials.
  • Provide support to coordinating client meeting, activities, and functions.
  • Participate in testing of all client related software and track all change requests.
  • Provide routine AD HOC reports from client software.
  • Provide contingency plan to continue administrative DCP support.
  • Provide support abstraction of clinical data from both (hardcopy and softcopy) into client database.

REQUIREMENTS:

  • Knowledge and experience with the Oncology Community.
  • Experience with document knowledge in clinical trial development processes (both scientific and administrative).
  • Knowledge of medical terminology.
  • Must have previous experience managing projects in monitoring clinical trials.
  • Strong written and verbal communication skills.
  • Strong interpersonal skills.
  • Excellent time management and conflict resolution skills required.
  • Ability to interact with all levels of managements.
  • Detail-oriented and possess good trouble-shooting skills.
  • Ability to prioritize and execute tasks in a high-pressure environment.
  • Proficient computer skills in Microsoft Office Suite.
  • Experience with (but not limited to) Clinical Trial databases.

EDUCATION:

  • Bachelor's Degree (Masters a plus) in life sciences, informatics, statistics, biostatistics, project management, data management or related field.

REQUIRED EXPERIENCE:

  • Minimum 3 years Clinical Trial Data/Research experience.
  • Minimum 2 years experience as a Project Leader or Project Manager.

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