Employment

Employment

 

The following are our currently available positions.

Job Description – Associate Director, Clinical Operations

 

Position Overview

The Associate Director, Clinical Operations will participate in the planning, coordinating, executing and completing of Phase 1-3 trials. This position may have leading roles in selected activities as assigned by the Executive Director of Clinical Operations in addition but not limited to providing CRO oversight to ensure site’s GCP/ ICH compliance, adherence to the study protocol, Aridis SOPs and federal and local regulations. In addition, this position will address daily issues from the CRO and sites and assure smooth conduct of the clinical trials, supervise and coordinate vendor activities to meet study requirements.

 

Duties and Responsibilities:

Oversee CRO activities coordinating all aspects of CRO management for tasks assigned to the CRO, as defined in the Task Order to ensure deliverables meet study objectives and timeline to assure overall efficient day-to-day management of clinical trials

Partner with the CRO to closely monitor trial progress, note any issues regarding enrollment, data quality and adherence to study procedures and address these issues in a timely fashion, and develop mitigation plans and managing budgets and resources

Oversee vendors; coordinating and conducting all aspects of vendor management within the contract scope to ensure stated objectives and deliverables are met

Investigational product inventory management and forecasting

Ensure document transfer activities to and update study documents to ensure information is accurate and complete in the Aridis TMF system

Assist in the preparation of study documents including protocols, eCRF and ICF development and provide input for study plans and study-related documents

Oversee trial progress through routine monitoring of eCRF entry and ensure timely entry and reporting of adverse events

Participates in site monitoring visits (co-monitoring), if appropriate

Review monitoring reports and follow up letters and note any issues identified; support CRAs to address these issues

Prepare study-related documents and templates

Assist Aridis Data Management in site Data Entry progress and query management

Review the quality and integrity of the clinical data through in-house review of electronic CRFs

Serve as an escalation point person and resource for internal team, CRO and vendors

Build excellent rapport with sites and CRO CRAs through regular email and phone contact and co-monitoring. Prepare contact reports as appropriate

Attend and contribute to study related, company and external meetings, as required

Attend Investigator Meetings for assigned studies, as required

Work closely with Aridis and CRO regulatory to ensure regulatory requirements are met

Ensure all study deliverables are completed within the study timelines

Provide communication to keep clinical and cross-functional teams informed and updated.

 

Requirements

Bachelor’s degree in clinical, biological or life sciences, nursing, or equivalent. Related field education/experience is required with at least 10 years of clinical trial experience

  • Minimum 8 years actively managing clinical studies years managing vendors/CROs is preferred.
  • Experience in Infectious diseases highly desired.
  • A thorough knowledge of FDA regulations, drug development and demonstrated proficiency of GCP and ICH is required.
  • Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills with team-oriented approach are required.
  • Excellent written/verbal communication skills and fluent in English are required.
  • Proficient computer skills using Word, Excel, PowerPoint, email and the internet are required.
  • Demonstrated self-starter with ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment is required.

 

Contact:

Please contact hiring manager 

Lynne Deans

deansl@aridispharma.com

JOB DESCRIPTION – Manager, Clinical Data Management

 

Position Overview

The Manager, Clinical Data Management will lead the data management components of one or more clinical trials ranging from small early phase to complex late phase global programs. This position is responsible for ensuring study launch, conduct, and closeout are performed according to Aridis quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all regulatory requirements. Duties include serving as the primary data management liaison with vendors and internal management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management, when needed.

·         Maintains effective communication through oral and written correspondence, project status and progress reports.

·         Manages the planning, implementation and overall direction of clinical trial data management activities including protocol review, Case Report Form (CRF) design, EDC/IWRS database development, systems validation, discrepancy management, creation of study documentation such as Data Management Plans (DMP), CRF Completion Guidelines (CCGs) and Data Review Plans.

·         Maintains and evaluates project progress by managing timelines, budgets and other tracking/analysis tools and prepares information for internal/external meetings.

·         Manages the interaction with vendors to ensure data management tasks remain on target according to project timelines.

·         Willingness to work on problems of a diverse scope and contribute to the development of departmental policies, standards and process improvement.

 

Requirements

·         Bachelor’s degree in clinical, biological, mathematical sciences, nursing, or equivalent related field education/experience is required.

·         Minimum 5 years actively managing clinical studies using Electronic Data Capture (EDC) with 2+ years managing vendors/CROs is preferred.

·         A thorough knowledge of FDA regulations, drug development and demonstrated proficiency of ICH, GCDMP, and GCP is required.

·         Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills with team-oriented approach are required.

·         Excellent written/verbal communication skills and fluent English are required.

·         Proficient computer skills using Word, Excel, PowerPoint, email and the internet are required.

·         Demonstrated self-starter with ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment is required.

 

Contact:

Please contact hiring manager

Clara Plascentia

plascenciac@aridispharma.com