Clinical Study Manager

Sterling-Hoffman Executive Search Located in: Minneapolis,  Minnesota
(Private and Secure - Guaranteed!)

Sterling-Hoffman Executive Search Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

We are on the lookout for a driven individual with a passion for the biotechnology industry. One of our clients is looking to add a strong Clinical Study Manager to their team:

1) Act as a customer advocate throughout the project lifecycle
2) Understand and support global project goals including site recruitment, patient recruitment, marketing and PR, as appropriate
3) Direct the development of study specific protocols, consent forms and other trial related materials (e.g., Study Monitoring Plan, Instructions for Use, etc.) as required
4) Make sure the appropriate development of all documents by CRO's including but not limited to study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates and other project-specific documents required for the conduct of assigned studies
5) Develop, manage and track clinical trial budgets to include review and approval of all vendor and site payments
6) Be responsible for notifying management of anticipated change orders and/or budget adjustments
7) Accomplish approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assume primary accountability for the ongoing progress
8) Co-ordinate with Clinical, Marketing and Operations management to identify goals and scope of clinical study projects
9) Manage and execute the overall project scope, budget and timelines
10) Initiate and train sites to the study protocol
11) Ensure proper site adherence to clinical research regulations
12) Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, central IRBs and contractual agreements
13) Support the management and oversight of CRO's and other clinical study related vendors
14) Plan for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment and investigational device
15) Ensure maintenance of document standardization through the use of model documents, templates and appropriate peer review
16) Ensure maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs)
17) Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities
18) Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required
19) Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
20) Develop and maintain detailed timelines and resource projections for all programs
21) Provide routine status reports and updates regarding the progress of programs
22) Work with Senior Clinical Study Manager to help ensure that internal project team members are trained appropriately to ensure proper study conduct
23) Prepare internal and external memos, reports, documents and correspondence required to properly manage and document activities on the studies
24) Manage the tasks that are not associated with in-life component of studies including, but not limited to: development of database, statistical analysis and report writing
25) Prepare and review clinical data for analysis
26) Manage relationships with consultants to provide adequate support and services for data collection and analysis
27) Attend off site-meeting and conferences, as needed

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the biotechnology industry is strongly preferred
    4) Preference will be given to people having recent experience in clinical study management

    If this seems like just the right opportunity to take your career to the next level, please apply - we want to hear from you!

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:
Management / Supervisory
Function:
  Clinical Research / Affairs,  R&D / Science,  Medical Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: