Study Manager I

Dm Clinical Research Group; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Dm Clinical Research Group is looking for a Study Manager to ensure quality research at assigned investigative sites, aligning with sponsor protocols, FDA regulations and ICH/GCP guidelines. The role emphasizes site readiness, enrolment targets, and timely data delivery.

The candidate will train site teams, enforce ALCOA-C standards, oversee adverse event reporting, and coordinate across functions to meet sponsor goals.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree preferred.
• Foreign Medical Graduates preferred.
• Minimum of 5 years experience in Clinical Research.
• Supervisory experience preferred.
• Regulatory research experience is a plus.
• ACRP or equivalent certification is preferred.

Responsibilities

• Completing all the DMCR-required training, including ICH-GCP Certification and IATA certifications.
• Maintaining knowledge of FDA regulations, ICH-GCP guidelines, SOPs, guidance documents and study protocol(s).
• Adherence to assigned protocols at their site(s).
• Training site teams and supporting the conduct of study visits and procedures.
• Enforcing ALCOA-C standards with all clinical trial documentation.
• Reporting adverse events to authorities per guidelines.
• Ensuring data quality, subject retention and timely reporting for assigned protocols.
• Collaborating with cross-functional teams to ensure site readiness and sponsor goals.
• Conduct patient consent discussions and explain study protocols clearly to participants.
• Attend Investigator Meetings as required.
• Manage from FPFV to study close-out with adherence to all protocols and manuals.

Skills

Leadership

Regulatory knowledge

Project management

Documentation

Communication

Training

Bilingual English/Spanish

Education

High School Diploma or equivalent

Bachelor's degree

Job description

A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.DUTIES & RESPONSIBILITIESCompleting all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).Adherence and compliance to the assigned protocols at their respective site(s).Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited toSponsor-provided and IRB-approved Protocol TrainingAll relevant Protocol Amendments TrainingAny study-specific Manuals Training as applicableSponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).Being prepared for and available at all required company meetings.Submitting required administrative paperwork per company timelines.Occasionally attending out-of-town Investigator Meetings.Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternativesProvide clear explanations of study protocols and ensure patients' understanding before obtaining their consentFacilitate effective communication between patients, healthcare providers, and research staffConduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternativesProvide clear explanations of study protocols and ensure patients' understanding before obtaining their consentFacilitate effective communication between patients, healthcare providers, and research staffAny other matters as assigned by management.KNOWLEDGE & EXPERIENCEEducation:High School Diploma or equivalent requiredBachelor's degree preferredForeign Medical Graduates preferredExperience:Minimum of 5 years experience in Clinical ResearchSupervisory experience preferredWide therapeutic range of clinical trials experience preferredRegulatory research experience is a plusCredentials:ACRP or equivalent certification is preferredKnowledge and Skills:Goals-driven while continuously maintaining quality.Must be detailed-oriented, proactive, and able to take initiative.Must have strong written and communication skills.Must have excellent customer service skills.Proficient communication and comprehension skills both verbal and written in the English language are required.Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred