Job Details

  • Title: Study Project Manager
  • Code: RCI-06811
  • Location: North Chicago Illinois (IL) 60064
  • Posted Date: 11/07/2019
  • Duration: 6 Months
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  Job Description

Description:

Must have at least 6 years of Pharma-related/clinical research related experience.

Bachelor's Degree or equivalent is required, typically in nursing or scientific field

Job Title : Study Project Manager I Purpose :

Describe the primary goals, objectives or functions or outputs of this position.
  • The Study Project Manager is responsible to connect science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies.
  • Contributes clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives.
  • The study project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.
Responsibilities :
  • Participates in innovation and process improvement initiatives.
  • Proactively identify and address and/or escalate study related issues and opportunities for efficiency
  • Responsible for the vendor selection, scope development, management and oversight of external vendors in compliance with Client processes and procedures and the applicable regulations
  • Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR)
  • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
  • Leads Clinical Study Team Meetings
  • Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and Client policies and procedures).
  • Leader of the cross functional study team:
  • Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones
  • Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
  • Responsible for study budget creation and oversight of spend against approved budget
  • Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
  • Decision maker on operational aspects of study execution.
  • Provides direct supervision of study management associate(s) including career development of clinical operationsstaff and creating an inclusive and innovative environment where staff and studies/programs will succeed
Qualifications :

List required and preferred qualifications (up to 10). Include education, skills and experience.
  • Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
  • Possesses good communication skills and demonstrated leadership abilities.
  • Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
  • Demonstration of successful coaching/mentoring in a matrix environment.
  • Preferred exposure in study initiation through Study completion in multiple phases of studies (Phase 1-3,4)
NOTES FROM MANAGER:

1) What hours and days will this person be working? Monday-Friday; 8-430pm
2) What is the length of the assignment, 6 months, one year, two years? 6 months
3) What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Experience conducting pharmaceutical and device studies, including combination drug/device studies
b. Required Skill 2: Knowledge and experience in compliance with device regulations US/Global, including EU MDR 2017 and ISO 14155
c. Required Skill 3: Ability to work collaboratively with upper management in development of quality documents (i.e., standard operating procedure and processes) for drug and device studies
d. Required Skill 4: Skilled in the use of Microsoft products (Word, Excel, SharePoint, OneNote)
4) What years of experience is required? 3-5 years
5) What level of education and/or certification is required? Bachelor
6) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Nothing more than what is in #3
7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? No, onsite
8) Other notable details about the environment from the hiring manager about this role N/A
9) What positions/background experience do you feel are successful in this role: Study Project Manager