Clinical Trial Manager

Viking Therapeutics, Inc.•San Diego, CA

1d•Onsite

About The Position

The Clinical Trials Manager (CTM) will support the conduct of clinical trials and data collection and review, monitoring adherence to protocols, and all activities related to trial completion. The CTM ensures timely conduct of clinical trials according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The CTM will interact internally and externally with members of cross functional trial team, and, externally with service providers, investigational site personnel, and others involved in the conduct of the business. The scope of this position requires excellent organizational, communication, and presentation skills, with strong experience in executing all phases of clinical trials. The position requires one to be on-site daily in the San Diego office and remote work is not an option.

Requirements

Bachelor’s Degree
Minimum 6 years’ relevant clinical trial experience in the pharmaceutical and/or biotechnology industry
Must have a demonstrated track record of managing clinical trials from Phase 1 to Phase 3
Strong knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements and clinical trial operations.
Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process, including but not limited to:
Site selection
Trial initiation procedures
Clinical monitoring functions
Data flow from sites to data processing, review, and resolution
Drug safety and regulatory affairs issues
Ability to exercise judgement within broadly defined practices and processes
Experience negotiating vendor/site contracts and managing the budgets
Solid vendor management skills, e.g. CRO, Laboratory, Clinical supply logistics
Developing and maintaining standard operating procedures and processes.
Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential and to ability to develop budgets and manage contracts.
Ability to edit technical documents, informed consent, and other trial-related documents.
Proficiency with computer programs including Microsoft Office suite and Microsoft Project.
Conduct training to ensure personnel are knowledgeable and familiar with internal process and job functions/duties.
Ability and willingness to travel 10-15% of the time.

Responsibilities

Manages trial operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s).
Supports all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
Ensure enrollment and data collection are completed in accordance with trial timelines and objectives; escalates risk to timelines and budget as needed.
Identifies and provides solutions to clinical trial issues and/or risks.
Proactively identifies project risks and resolves with some supervision.
Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated.
Serve as a liaison and resource for investigational sites.
Assists with preparation of RFP's and bid templates to facilitate selection of the CRO's/vendors.
CRO Selection: Assist with review of proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
Participates in the selection of trial vendors for assigned trials.
Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed.
Oversee clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, trial site personnel, CRAs, and other CRO/designee personnel.
Coordinate the design, format and content of CRFs, trial guides, trial reference binders, patient diaries, and forms including participating in the EDC and specification process and UAT.
Contributes to relevant trial documentation including clinical protocols, statistical analysis plan, clinical trial reports as well as operational plans (CMP, DMP).
Reviews and refines clinical operational plans including the trial monitoring plan and other study plans as needed.
Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.
Participates in the selection of investigational sites with input from Clinical Research and vendors.
Identify potential trial issues and recommend and implement solutions or corrective actions as needed.
Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
Performs other duties as required.