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Celerion · 1 day ago

Lead, Clinical Monitoring Services - Arizona

Tempe, AZ

Full-time

Onsite

Senior Level

5+ years exp

Celerion is committed to swift, exceptional clinical research through translational medicine. They are seeking a full-time Lead, Clinical Monitoring Services person to oversee monitoring and site management activities for clinical trials, clinical investigations, and other interventional or non-interventional studies.

Health CarePharmaceutical

Responsibilities

Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies that are executed at the sites conducting clinical research studies

Direct supervision / line management of CRA staff and contractors in the team in accordance with Celerion policies and applicable regulations

Interview, hire, and conduct onboarding training for new staff in conjunction with Human Resources; ensure that staff has the proper materials, systems access and training to complete job responsibilities

Prepare and implement function specific training programs; ensure training on and adherence to Celerion’s procedures and guidance documents, best business practices, legal and confidentiality constraints

Assign staff members to clinical projects, monitor staff workload, and liaise with the Manager of Monitoring, GCD North America (as needed) to ensure appropriate allocation of resources and optimal utilization

Ensure timely submission of timesheets and expense reports by staff as well as review/approve timesheets and expense reports in a timely manner

Develop, mentor, manage and coach CRA staff to progress their skills so that the organization's quality standards are maintained

Perform annual appraisals, define the performance objectives and advocate individual career development, responsibility and accountability

Serve as escalation line for direct reports, including trouble shooting, issue escalation, deviation management, QI/CAPA management

Advocate for the needs of the staff with other functions of the organization

Generate action plans and provide developmental/strategic oversight to optimize monitoring services, with a focus on high quality delivery of individual/team/departmental goals

Maintain a positive, results oriented work environment, build partnerships, model teamwork, and communicate in an open, balanced, and objective manner

Contribute to Process Improvement initiatives for Line of Service (LOS)

Support day-to-day execution of monitoring services for the ongoing projects; ensure deliverable of the CRAs assigned to the projects are met on time within quality and budget parameters according to the Sponsor/Client expectations

Implementation and monitoring of clinical studies to ensure sponsor and investigator obligations are being met in compliance with local regulatory requirements, Good Clinical Practice, and the respective protocol or investigational plan as follows:

Ensure monitoring activities are occurring according to contract, monitoring plan and SOPs

Oversee and assist with monitoring plan and study material development (SIV Slides, SQV Waivers, etc.)

Co-monitor as needed

Update and review of clinical trial management tracking systems (CTMS)

Manage all monitoring activities within CTMS (visits, open and closed queries, issues opened)

Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings/training with pertinent departments and other vendors

Review monitoring metrics/deliverables to evaluate quality trends and compliance to monitoring plan

Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary

Interact with Clinical Project Manager/designate and other study team members to ensure timely resolution of project study issues

Participate and demonstrate proactive involvement in project study meetings, internal project study meetings, and other activities enhancing project progress

Participate in audits and inspections, including preparation and follow-up activities as needed

Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements

May act as a CRA for selected studies where needed and defined

Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client

Be thoroughly familiar with and follow all applicable procedures and policies (standard and study specific)

Interact with direct supervisor and the study team to develop a thorough and unambiguous understanding of all tasks required as well as project study timelines and priorities

Maintain a working knowledge of all required Celerion IT systems

Follow administrative and reporting/documentation requirements of Celerion and clients , as necessary

Agree to be subjected to audits, compliance, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associates

Perform other duties as assigned

Qualification

Clinical Operations ExperiencePeople ManagementClinical PracticeBiomedical DegreeRegulatory KnowledgeOral CommunicationWritten CommunicationTime ManagementAttention to DetailSelf-MotivationTeamworkConfidentiality

Required

Bachelor's degree in a biomedical-related field, life sciences or equivalent field

At least 5 years or more in clinical operations or related discipline either in CRO or Pharmaceutical industry with a minimum of 3 years onsite monitoring experience

People Management skills required

Excellent oral and written communication skills in English

High level of organization, multi-tasking, judgement, and analytical skills

Good time management skills to ensure adherence to timelines

Profound knowledge of Good Clinical Practice, 21 CRF Part 11, and other relevant regulatory requirements

Dedication to quality and reliability

Commitment to continuous training and knowledge sharing; proactively keeping up to date with procedural industry standards and international regulatory developments in clinical research

Ability to work well independently and as part of a team

Self-motivation

Maintain confidentiality of Subject data and Sponsor/Client information

Computer literate

Strong attention to detail while being tactful and diplomatic

Ability to conduct all types of site visits according to Celerion/Sponsor SOPs, GCP, and regulatory requirements

Experience in performing Feasibilities, Site Qualification Visits, Initiation Visits, Investigational Product Accountability, Routine Monitoring Visits, Close Out Visits and in maintaining Trial Master Files and handling SAEs

Flexible and willing to drive to the Tempe, Arizona site for both pre-planned and impromptu meetings/visits