Sr. Clinical Trial Manager

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At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms. We foster an inclusive and collaborative workplace where everyone feels welcome, respected and valued.

Essential Functions:

In this role,you will be responsible for the strategic planning, successful implementation and management of clinical trials that includes: CRO/vendor and study site selection, set-up and oversight, as well as management of the recruitment, execution and completion of clinical trials. This role will ensure clinical trials are executed with agreed upon project priorities, timing, budget, and quality requirements. You will build and maintain strong, collaborative relationships across all DICE functional areas that interact with Clinical Operations, to enable successful completion of all clinical activities and project deliverables. You may support additional clinical trial(s) in various capacities (e.g., leading Clinical Pharmacology studies, unblinded Clinical Trial Manager etc.) You will be responsible to assure adherence to GxP in conduct of DICE clinical trials, with your primary objectives being the quality and integrity of generated data, and the rights and welfare of participants /patients.  You must have a positive, proactive, creative mindset and be open to navigating the ambiguity of a start-up environment. Proven leadership and the ability to work in a fast-paced environment are essential for this position.

Key Responsibilities:

  • Leads cross-functional study teams manages all operational aspects of the assigned clinical trial(s) and oversees clinical trial conduct including vendor selection, study start-up, enrollment, study conduct and close-out
  • Accountable for operational study-level time, cost and quality deliverables assures studies are carried out according to the study protocol, SOPs, study-specific manuals and procedures, as well as DICE quality standards 
  • Leads and /or contributes to the development of study-related and essential documents/plans
  • Leads the identification, evaluation, selection, oversight of clinical trial sites
  • Develops and oversees study-specific training plans and Investigator Meetings; plays a key role in representing DICE through delivery of presentations at Investigator Meetings
  • Interfaces with cross-functional teams as Clinical Operations study lead (e.g., Medical Monitor, Regulatory, Data Management, CMC/Supply Chain, CRO, vendors and Investigators/site staff)
  • Manages and updates key metrics and dashboards required for senior leadership
  • Ensures that the Trial Master File is set up and maintained appropriately throughout the trial
  • Participates in the review of clinical data in the EDC, data cleaning activities; ensures that all study data and documentation meet FDA/GCP/ICH regulations
  • Expands knowledge of clinical trial operations /scientific principles under minimal direction and recognizes when to escalate issues with solid communication skills
  • Manage multiple clinical study vendors with oversight of activities
  • Establishes mechanisms for quality /risk management oversight
  • Provides oversight of activities related to site qualification, initiation, interim monitoring, and close-out visits
  • Participates in RFP and vendor selection in collaboration with Vendor & Operations Manager
  • Leads or contributes to key or interdepartmental initiatives/projects
  • Assists in preparing for and responding to audit findings in collaboration with GCP QA
  • Provides training and mentorship to junior Clinical Operations staff, participates in hiring activities
  • Travel required: potential domestic and international travel

Preferred Experience and Education:

  • Bachelor’s degree in scientific field, or equivalent training and experience
  • Minimum of 5 years of direct experience in Trial Management role (Sponsor preferred)
  • Early Development experience required. Start-up experience a plus
  • Experience Immunology therapeutic areas and/or Clinical Pharmacology trials is preferred
  • Well-versed in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
  • Proven ability to manage multiple projects while maintaining high quality
  • Expertise in CRO & vendor management
  • Excellent leadership skills/ability to lead cross-functional teams of professionals
  • Excellent attention to detail
  • Highly motivated self-starter
  • Solution-oriented mindset
  • Respectful of others and is a team player
  • Proficiency in MS Office (Word, PowerPoint, MS Project), expertise in Excel

Position is based in South San Francisco, with potential for flexible work arrangements 

Salary range 160,000- 180k (Bay Area)

The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.

DISCLAIMER

The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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