Principal Investigator

Sterling-Hoffman Executive Search Located in: Nebraska
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JOB DESCRIPTION

Our client, a leading pharmaceutical company, is currently seeking an accomplished Principal Investigator to join the team. Here is an overview of the role:

1) Review protocol and investigator brochure for subject safety, scientific and operational feasibility of study
2) Provide input to sponsor as indicated
3) Complete FDA 1572 and financial disclosure forms
4) Attend study initiation meetings with sponsor
5) Communicate with Institutional Review Board during protocol approval process and subject safety issues
6) Ensure proper consent and perform screening examination
7) Review all screening data and authorization of subjects to be enrolled in the study
8) Perform scheduled per protocol and unscheduled per adverse events and physicals during study conduct
9) Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity and etiology
10) Review pre-dose lab work, ECGs and other study data and determine appropriate action plan based on these results
11) Review safety data with sponsor
12) Compose SAE and other reporting documents as indicated
13) Review and sign case report forms and final clinical study reports
14) Review all serious adverse events and  present SUSARs to the sponsor and IRB within statutory timelines
15) Review all end-of-study data to determine if re-checks are necessary
16) Assist with identifying and maintaining a network of physician specialists to contract on studies
17) Present company’s capabilities and experiences during sponsor meetings and events
18) Perform as a medical/clinical informational resource for the site
19) Assist other departments with development of SOPs, training plans, etc.
20) Facilitate emergency response training and review of clinical safety procedures
21) Manage staff in accordance with the organization's policies and applicable laws
22) Interview, hire and train employees
23) Plan, assign and direct work
24) Appraise performance, reward and discipline employees, address complaints, resolve problems and develop and coach employees

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the pharmaceutical industry is strongly preferred
    4) Preference will be given to candidates with recent experience in investigation

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Medical Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: