|Sunrise Systems Inc|
US-Northeast, Sr Regional Site Manager SrRegionalSiteManager-NY-MZ
Job Title: Senior Regional Site Manager
Location - Northeast Region NY, NJ, CT or MA.
Duration - 1 year
Type - Contract W2 Only
Rates - Hourly Depends on Experience
I. POSITION SUMMARY
The Senior Regional Site Manager (Senior RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected. The Senior RSM conducts all monitoring visits in accordance with clientsstandards. The Senior RSM exercises responsibility across multiple projects and therapeutic areas. The Senior RSM interfaces with clinical investigators, other site staff and Clients personnel in order to carry out this responsibility. The Senior RSM is completely accountable for site management and data quality for each assigned site. In addition, the Senior RSM may hold other assignments, such as Lead Site Manager, Global Site Management Operations Subject Matter Expert (SME), Contract Research Organization (CRO) Oversight Representative, or any other project assigned by Global Site Management Operations management.
The Senior Regional Site Manager is a regional home based position.
II. PRIMARY JOB RESPONSIBILITIES:
1. Conduct the following monitoring visits according to applicable Clients SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines as follows:
• Site Qualification Visits (SQVs)
• Site Initiation Visits (SIVs)
• Interim Monitoring Visits (IMVs)
• Remote Monitoring Visits (RMVs)
• Close-out Visits (COVs)
2. Manage all site activities for assigned sites including:
• Partnering with sites to ensure recruitment goals are met.
• Assisting sites with operational needs (e.g. vendor activities, site payment).
• Primary contact for all issues that arise with sites.
3. Communicate site status and monitoring activities, as follows:
• Submit monitoring visit reports (MVRs) for all monitoring visits conducted.
• Send follow-up letter to Principal Investigator summarizing visit conduct and all action items.
• Contact the Regional Operations Manager (ROM) and Project Lead (PL) regarding significant site conduct issues.
• Complete GXP Compliance audit responses in conjunction with ROM and PL.
4. Meet all departmental timelines and deliverables for the following activities:
• Submission of MVRs in CTMS.
• Submission of MVRs to the TMF (if applicable).
• Retrieval of all paper case report forms (if applicable).
Perform monitoring visits per window specified in monitoring plan
• Maintenance of calendar.
• Submission of weekly time and expense reports.
5. Attend and participate in all relevant meetings, as follows:
• Annual Global Site Management Operations meeting
• Regional Global Site Management Operations meetings, as scheduled.
• Investigator Meetings for all assigned studies.
• Regional Site Manager teleconferences for all assigned studies.
• Regular regional teleconferences.
In addition to the primary responsibilities of site monitoring, the Senior Regional Site Manager may also hold specialized roles in one or more of the following areas:
6. As a Lead Site Manager:
• Review and provide input to protocols and Case Report Forms.
• Act as primary author for Protocol-Specific Monitoring Plan.
• Present monitoring plan and monitoring expectations at the Investigators meeting.
• Maintain SharePoint and/or Global Site Management Operations portal with study-specific information.
7. As a Global Site Management Operations Subject Matter Expert (SME):
• Present at regional and annual meetings for Global Site Management Operations.
• Present components of Global Site Management Operations Orientation to newly hired Global Site Management Operations personnel.
• Assist in development and maintenance of the Global Site Management Operations Orientation program.
8. As an Oversight Representative on clients projects managed by CROs:
• Participate in regular meetings between clients and the CRO Conduct Monitoring Oversight Visits to clinical research sites.
• Review and provide input to protocols, Case Report Forms, and monitoring plans.
• Review Monitoring Visit Reports and provide feedback.
III. ADDITIONAL JOB RESPONSIBILITIES:
The Senior RSM is also responsible for any other projects assigned by Global Site Management Operations management.
IV. POSITION QUALIFICATIONS:
Allied Health Professions degree (PA, RN, RPh), relevant clinical experience or four-year life science degree.
Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization (5 years preferred)
Experience working in more than one therapeutic area
Familiar with Electronic Data Capture preferred
Experience with Risk Based Monitoring preferred
Knowledge, Skills, and Abilities
Strong knowledge, understanding, and application of monitoring SOPs and Good Clinical Practice
Good working knowledge of the drug development process
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook,
Must possess excellent skill/ability in the following:
Written and Oral Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Influencing Others, Motivating Others, Team Building
Initiative and Accountability
Possessing management skill/ability in the following is a plus:
Maintaining activities and Coordinating activities
Training new team members
Ability to communicate clearly with a variety of professional and medical personnel
Strong ability to work independently toward completion of assignments
Skilled at teaching and training others
While performing the duties of this role, the candidate:
Must work effectively and efficiently in a home-based office environment
Will maintain a fully functional home office (high speed internet connection, office phone, copier, etc.)
May potentially travel overnight an average of 50%
May be required to lift more than 25 pounds, in association with travel requirements.
Must maintain a credit limit that would support routine business travel expenses.
Sunrise Systems Inc
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