Medidata Rave Jobs in California (NOW HIRING)

The Executive Director, CDM Operations Lead is a management role overseeing the day-to-day operations of the Clinical Data Management execution team. This role will report to the VP, CDM and sit on the Data Management Leadership Team (DMLT) with contributions to the strategic development of the department and accountable to the tactical execution of clinical trials and related work streams. This role is responsible for overseeing timelines, data quality, and data integrity across all clinical trials, ensuring compliance with GCP, GCDMP, SOPs, Health Authority and regulatory requirements.

The Ops Lead role requires an in-depth understanding of clinical data management best practices, data collection strategies, data flow management, assessing data quality, and ensuring data integrity for the full development life-cycle. This role must also have expertise in data archiving, submissions and inspection preparedness.

The Ops Lead will work closely with cross functional operational teams and external partners as point of contact for vendor management. The position also supports clinical development and internal projects, manages scientific and data-related queries, and operates independently within established Tyra Biosciences procedures and practices.

Key Job Responsibilities

• Represents Data Management in study and program level leadership team meetings regarding strategic planning and execution capacity.
• Supervisor responsibilities for all operational roles, Lead data managers, clinical data coordinators, clinical programmers, lab specialist among others
• Author, edit or review data management SOPs and contribute to review other departmental SOPs and provide training on data management topics
• Supports the Lead DM at study management team meetings.
• Creation of program level data collection strategy
• Manage day-to-day operations, study allocation, and career development of direct and indirect reports
• Support trial designs and approach for data driven decision framework
• Understand DM resourcing strategies to meet the current program/study needs
• Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables
• Ensure data collection strategies are understood and effectively incorporated into protocol, data collection, validation and DM documents consistently across all programs
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection, validation and DM documents
• Participate in vendor RFI/RFP/Bid/Selection process for all vendors that will perform work on behalf of Tyra and its data
• Work with vendor partners to increase vendor/partner efficiencies
• Monitors the progress of activities on all studies to ensure project timelines are met
• Proactively identify program and delivery issues/risks and recommends/ implements solutions
• Participate in the evaluation and enablement of technology-enabled workstream automations
• Provide coaching/mentoring to LDMs and other DM colleagues
• Work with project sponsors, stakeholders, and cross-functional team members to help define operational project requirements, scope, risks, organization and approach.
• Oversee CRF development to ensure alignment with protocol objectives, regulatory standards, and data collection best practices.
• Accountable for data review, cleaning, and quality control to ensure high quality analysis ready data deliveries
• Other tasks as assigned by management.

Education & Experience Required

• A 4-year degree (BA/BS) from a recognized university in Life Sciences, Business, Computer Science, or Mathematics or comparable work experience
• 20+ years of experience in the drug development industry and biometrics, prefer sponsor experience over CRO.
• 10+ years of people management and leadership experience
• 5+ years of oncology experience
• Expertise in medical coding, MEDDRA and WHO DRUG
• Proficiency in the development and use of commercial EDC products and other common trial management systems (preference given for Medidata Rave)
• Experience in Early Phase Development studies
• Experience or familiarity with healthy subject Clinical Pharmacology studies.
• Proficiency in use of Microsoft Suite products for the purpose of gathering and providing information to cross-functional team members
• Manage and maintain the Data Management (e)TMF, contributing to the Trial (e)TMF
• Demonstrated ability to work independently and in a team environment
• Applied knowledge of FDA, EMA, Health Canada and other significant Health Authority regulations
• Applied knowledge of CDISC and CDASH guidance standards.
• Excellent interpersonal skills
• Excellent project management and organizational skills in clinical trials setting
• Excellent communication and presentation skills, both documented and verbal

Pay Range and Benefits

Base Salary Range: $ $306,561 - $321,837 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.