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Executive Director, CDM Operations Lead
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Tyra Biosciences
Oceanside, CA (In Person)
$189,434 Salary, Full-Time
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Job Description
Executive Director, CDM Operations Lead at Tyra Biosciences Executive Director, CDM Operations Lead at Tyra Biosciences in San Luis Rey, California Posted in 10 days ago.
Supervisor responsibilities for all operational roles, Lead data managers, clinical data coordinators, clinical programmers, lab specialist among oth ersAuthor, edit or review data management SOPs and contribute to review other departmental SOPs and provide training on data management top icsSupports the Lead DM at study management team meetin gs.
Creation of program level data collection strat egyManage day-to-day operations, study allocation, and career development of direct and indirect repo rtsSupport trial designs and approach for data driven decision framew orkUnderstand DM resourcing strategies to meet the current program/study ne edsDevelop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverab lesEnsure data collection strategies are understood and effectively incorporated into protocol, data collection, validation and DM documents consistently across all progr amsEffectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection, validation and DM docume ntsParticipate in vendor RFI/RFP/Bid/Selection process for all vendors that will perform work on behalf of Tyra and its d ataWork with vendor partners to increase vendor/partner efficienc iesMonitors the progress of activities on all studies to ensure project timelines are metProactively identify program and delivery issues/risks and recommends/ implements soluti onsParticipate in the evaluation and enablement of technology-enabled workstream automati onsProvide coaching/mentoring to LDMs and other DM colleag uesWork with project sponsors, stakeholders, and cross-functional team members to help define operational project requirements, scope, risks, organization and approa ch.
Oversee CRF development to ensure alignment with protocol objectives, regulatory standards, and data collection best practic es.
Accountable for data review, cleaning, and quality control to ensure high quality analysis ready data deliver iesOther tasks as assigned by manageme nt. Education & Experience Requ iredA 4-year degree (BA/BS) from a recognized university in Life Sciences, Business, Computer Science, or Mathematics or comparable work experi ence20+ years of experience in the drug development industry and biometrics, prefer sponsor experience over CRO.10+ years of people management and leadership experi ence5+ years of oncology experi enceExpertise in medical coding, MEDDRA and WHO DRUGProficiency in the development and use of commercial EDC products and other common trial management systems (preference given for Medidata R ave)Experience in Early Phase Development stu diesExperience or familiarity with healthy subject Clinical Pharmacology stud ies.
Proficiency in use of Microsoft Suite products for the purpose of gathering and providing information to cross-functional team mem bersManage and maintain the Data Management (e)TMF, contributing to the Trial (e )TMFDemonstrated ability to work independently and in a team environ mentApplied knowledge of FDA, EMA, Health Canada and other significant Health Authority regulat ionsApplied knowledge of CDISC and CDASH guidance standa rds.
Excellent interpersonal sk illsExcellent project management and organizational skills in clinical trials set tingExcellent communication and presentation skills, both documented and ve rbal Pay Range and Ben efits
Competitive base, bonus, new hire and ongoing equity pa ckagesThe starting compensation range(s) for this role is for a full-time employee (FTE) basisBenefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enro llmentEmployer-paid Medical, dental, and vision ins uranceEmployer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP co verage401(k) Plan with a fully vested company match 1:1 up to 4% of contrib utionsEmployee Stock Purchas e Plan14 -18 paid holidays, including office closure between December 25th and Janua ry 1stFlexible va cationSic k timeFitness P rogramGet Outdoors P rogramPaid parental leave b enefitTuition assi stance J ob
Type:
full-timeJob Description:
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 Lea d 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 Th e Ops Le ad 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 practice s.Key Job Responsibiliti es:
Represents Data Management in study and program level leadership team meetings regarding strategic planning and execution capaci ty.Supervisor responsibilities for all operational roles, Lead data managers, clinical data coordinators, clinical programmers, lab specialist among oth ersAuthor, edit or review data management SOPs and contribute to review other departmental SOPs and provide training on data management top icsSupports the Lead DM at study management team meetin gs.
Creation of program level data collection strat egyManage day-to-day operations, study allocation, and career development of direct and indirect repo rtsSupport trial designs and approach for data driven decision framew orkUnderstand DM resourcing strategies to meet the current program/study ne edsDevelop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverab lesEnsure data collection strategies are understood and effectively incorporated into protocol, data collection, validation and DM documents consistently across all progr amsEffectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection, validation and DM docume ntsParticipate in vendor RFI/RFP/Bid/Selection process for all vendors that will perform work on behalf of Tyra and its d ataWork with vendor partners to increase vendor/partner efficienc iesMonitors the progress of activities on all studies to ensure project timelines are metProactively identify program and delivery issues/risks and recommends/ implements soluti onsParticipate in the evaluation and enablement of technology-enabled workstream automati onsProvide coaching/mentoring to LDMs and other DM colleag uesWork with project sponsors, stakeholders, and cross-functional team members to help define operational project requirements, scope, risks, organization and approa ch.
Oversee CRF development to ensure alignment with protocol objectives, regulatory standards, and data collection best practic es.
Accountable for data review, cleaning, and quality control to ensure high quality analysis ready data deliver iesOther tasks as assigned by manageme nt. Education & Experience Requ iredA 4-year degree (BA/BS) from a recognized university in Life Sciences, Business, Computer Science, or Mathematics or comparable work experi ence20+ years of experience in the drug development industry and biometrics, prefer sponsor experience over CRO.10+ years of people management and leadership experi ence5+ years of oncology experi enceExpertise in medical coding, MEDDRA and WHO DRUGProficiency in the development and use of commercial EDC products and other common trial management systems (preference given for Medidata R ave)Experience in Early Phase Development stu diesExperience or familiarity with healthy subject Clinical Pharmacology stud ies.
Proficiency in use of Microsoft Suite products for the purpose of gathering and providing information to cross-functional team mem bersManage and maintain the Data Management (e)TMF, contributing to the Trial (e )TMFDemonstrated ability to work independently and in a team environ mentApplied knowledge of FDA, EMA, Health Canada and other significant Health Authority regulat ionsApplied knowledge of CDISC and CDASH guidance standa rds.
Excellent interpersonal sk illsExcellent project management and organizational skills in clinical trials set tingExcellent communication and presentation skills, both documented and ve rbal Pay Range and Ben efits
Base Salary Range:
$ $306,561 - $321,83 7 USDIndividual compensation will be determined based on factors such as work location, skills, education, training, and experi ence. What we offer US-based Empl oyees:Competitive base, bonus, new hire and ongoing equity pa ckagesThe starting compensation range(s) for this role is for a full-time employee (FTE) basisBenefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enro llmentEmployer-paid Medical, dental, and vision ins uranceEmployer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP co verage401(k) Plan with a fully vested company match 1:1 up to 4% of contrib utionsEmployee Stock Purchas e Plan14 -18 paid holidays, including office closure between December 25th and Janua ry 1stFlexible va cationSic k timeFitness P rogramGet Outdoors P rogramPaid parental leave b enefitTuition assi stance J ob