Clinical Study Manager

Job Description

• The Study Specialist will augment activities performed by existing study team members whether from client or client’s preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables.

• This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development.

• Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety.

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.

Qualifications

BS/MS

Additional Information

For more information, please contact

Akriti Gupta

(973) 967-3409 

Morristown, NJ 07960