Clinical Systems Project Manager

Worldwide Clinical Trials

Posted on: September 21, 2022

Closing: October 21, 2022

Salary: Undisclosed

Position Type: Regular

Job Description

SUMMARY: Plans and manages the successful delivery of assigned clinical systems projects by ensuring high quality execution and work products and by meeting the established project budget and schedule

RESPONSIBILITIES:
Tasks may include but are not limited to:
  • Plan project scope and timelines to ensure successful delivery by defining scope deliverable in shorter timelines (thereby breaking larger scope efforts into multiple smaller phased projects), by ensuring the availability of all necessary participants, and by identifying risks and corresponding mitigation plans
  • Provide oversight and accountability of deliverables, ensuring they meet Worldwide SOP's, current Good Clinical Practice (GCP) and other applicable regulations
  • For projects that are a part of a larger effort, collaborate with other project managers and key stakeholders to ensure the project timeline aligns with the overall timeline and where possible allows for minor adjustments that do not impact the overall timeline
  • Liaise with staff and management as applicable to manage project budgets
  • When applicable, ensure that vendor contracts, budgets, schedules, and deliverables align with the project needs
  • Proactively identify the incidence of additional scope and work with stakeholders to determine the appropriate course of action, raising change orders as needed
  • Continuously assess project status, reassess and revise risks, oversee issue documentation and escalation, and ensure the project team and stakeholders remain informed of project status, risks, and issues throughout the project (including both periodic project health updates as well as ad hoc communications for emerging impacts)
  • Collaborate with functional leads to identify, evaluate, and communicate project requirements, assign and revise assignment of resources, to interpret and resolve project issues, and to ensure all project objectives and work products are completed
  • Coordinate or execute resourcing change and task progress updates to the project resource management system
  • Coordinate and lead well-organized project meetings, and ensure minutes and action items are distributed
  • Apply general business expertise and/or seek and implement advice from appropriate subject matter experts to make informed decisions that lead to project success
  • Author the clinical systems project plan
  • Review and provide approval for project documents authored by other project team members or vendors, ensuring alignment with project objectives, Worldwide SOPs, and regulatory requirements
  • Ensure all project documentation is filed timely, is complete and accurate, and is signed as appropriate
  • Coordinate and ensure completion of user acceptance testing by appropriate stakeholders as required
  • Coordinate installation and operational qualification where applicable
  • Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required for projects that include study IRT delivery
  • Perform QC checks of manual database edits and other tasks where required
  • Provide oversight and support of assigned ongoing studies, including periodic on-call support when required
  • Provide first-line and second-line support where appropriate to clinical systems supported by the Clinical Systems Department
  • Coordinate the identification, documentation, and management of incidents that occur both within as well as outside of project delivery
  • Attend off-site Investigator Meetings and other types of project related meetings when required
  • Contribute to the identification, creation, and improvement of key performance indicators to identify actionable issues and opportunities for improvement
  • Compile and disseminate KPIs and other project metrics in alignment with project requirements and department standards for project metrics
  • Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
  • Contribute to the identification and implementation of process improvement initiatives
  • Perform other duties as assigned

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

  • Ability to communicate concisely and effectively in both written and spoken English
  • Proficient client-facing skills
  • Proficient in the use of common office software
  • Self-motivated individual who can positively contribute to a team environment
  • High attention to detail
  • Ability to prioritize and handle multiple projects simultaneously
  • Flexible and able to use sound independent judgment and take initiative to assess information
  • Able to make effective decisions in a fast-paced, highly dynamic environment
  • Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems

REQUIREMENTS:

  • Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
  • Minimum 2 years' project management experience
  • Minimum of 5 years experience within CRO /pharma environment
  • Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
  • Contract Research Organization (CRO) or Pharmaceutical experience required
  • Possessing an in-depth understanding of project management expectations and practices with ability to work to and direct project plans
  • Familiar with IRT topics, including IRT study design, randomization methodologies, and just-in-time drug supply
  • Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
  • Proven ability to manage delivery of technology solutions deployed in clinical trials - such as IRT, RTSM, CTMS, EDC or other relevant technologies desired
  • Familiarity with GxP Validation Requirements


Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Worldwide Clinical Trials

Posted on: September 21, 2022

Closing: October 21, 2022

Salary: Undisclosed

Position Type: Regular

Career Focus: Clinical Operations

Similar Jobs


Cincinnati, United States

Clinical Trial Manager

Job Summary Medpace is the leading CRO for Biotech companies and is cont...

Durham, United States

Clinical Study Specialist

At BioCryst, we are passionate about advancing novel therapeutics for pa...

Princeton, United States

Senior Manager / Associate Director,...

Genmab is focused on the creation and development of innovative and diff...

Princeton, United States

Senior Clinical Start Up Manager

Genmab is focused on the creation and development of innovative and diff...