Clinical Study Manager-Remote(Job Id- 3908-1)

Artech Information System LLC; United States; Remote; USD 100,000 - 160,000; Full time

Job summary

Artech Information System LLC seeks an experienced Study Manager to drive site start-up, maintenance and close-out, ensuring patient safety and data quality. You will work with clinical operations teams, sponsors, and CROs to resolve site issues and achieve enrollment readiness.

The role requires on-site monitoring at times, candid collaboration across stakeholders, and willingness to travel up to 50% to support multiple sites. Strong knowledge of FDA regulations and GCPs is essential.

Qualifications

• Bachelor’s Degree in Life Science required.
• Minimum 5 years of study management experience, preferably in Rare Diseases.
• Experience in on-site monitoring of clinical trials.
• Knowledge of FDA regulations and GCPs.

Responsibilities

• Remove obstacles to site start-up, maintenance and close-out while engaging site staff.
• Identify and interpret problems, drive resolution and influence changes.
• Liaise with site, sponsor and CRO to resolve issues and initiate sites.
• Escalate clinically identified site issues to PM or designee.
• Support the management of multiple academic sites with coordination and support.
• Protect the rights, safety and data integrity of subjects.

Skills

Problem solving

Site management

Regulatory knowledge

Communication skills

Travel readiness

Education

Bachelor's Degree in Life Science

BS/MS

Job description

Organizational Relationships

• Oversight by client Clinical Operations Study Team Lead
• Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur
• Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead)

Primary Duties

• Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff
• Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes
• Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites
• Point of escalation for clinically identified site related issues
• Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee
• Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support)
• Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality
• Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file
• Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client
• Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training.
• Complies with all departmental objectives and metrics related to study execution
• Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge

Secondary Duties

• As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs
• As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution
• Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study
• Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan

Training and Education Preferred

• Bachelor’s Degree in Life Science, RN preferred
• Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring
• Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable)
• Demonstrated ability to problem solve and to prioritize site related activities
• Demonstrates solid understanding of drug development and clinical practices
• Understands and is able to comprehend study protocols
• Has knowledge of FDA regulations
• Possesses working knowledge of GCPs and other regulations governing clinical research
• Demonstrates technical expertise in computer skills
• Demonstrates diligent and self-motivated approach to working in an independent environment
• Demonstrates effective oral and written communication skills
• Travel anticipated at 25% but could up to 50% at times.
• BS/MS

Contact Information

For more information, please contact Akriti Gupta [phone] Morristown, NJ 07960

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.