Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

81 days ago

Salary

$145K - $160K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Trial Manager

Apogee Therapeutics

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met • Initiate and build strong relationships with key opinion leaders and clinical site staff • Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions • Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data • Proactively identify and manage study related risks • Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents • Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan • Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions • Review CRO and vendor contracts/work orders and specifications to align with study objectives • Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC) • Participate in data cleaning and manage database lock activities with cross functional team • Oversee review and approve essential document packages to enable timely site activations • Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary • Participate in TMF review and ensure quality and completeness throughout end of the study • Ensure the study is always “inspection ready” • Oversee and coach the functional activities of Clinical Trial Associates allocated to the project

Job Requirements

  • Bachelor’s degree in life science or equivalent
  • Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization. Biotech experience strongly preferred.
  • Prior phase II and III experience required
  • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
  • Proven proficiency in overseeing complex studies being managed in house and by a CRO
  • Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
  • Experience selecting and managing clinical vendors to support study activities
  • Enjoys building relationships with KOLs and site personnel
  • Demonstrated ability to build and deliver on patient enrolment strategies
  • Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
  • Demonstrated ability to review and comprehend complex scientific concepts and clinical data
  • Strong planning, time management, and coordination skills
  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  • Excellent written and oral communication skills
  • Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.

Benefits

  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
  • Commitment to growing you professionally and providing access to resources to further your development
  • Apogee offers regular all team, in-person meetings to build relationships and problem solve

Related Categories

Related Job Pages

More Clinical Research Jobs

Everest Clinical Research logo

Principal Biostatistician

Everest Clinical Research

Quality is Our Backbone. Customer-focus is Our Tradition. Flexibility is Our Strength.

Full TimeRemoteTeam 501-1,000Since 2004H1B Sponsor

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal Biostatisticians for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. Key Accountabilities: Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects. Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting. Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects. Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals. Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels. Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan. Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others. Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements. Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients. Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians. Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations. Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions. Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC). Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents. Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants. Qualifications and Experience: A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience OR A Master’s degree in the above fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance. Everest is inviting candidates to apply for this existing vacancy. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary Range: $150,000 - $200,000. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-REMOTE #LI-TK1 #INDHP

Canada
$150K - $200K / year
Everest Clinical Research logo

Senior Biostatistician

Everest Clinical Research

Quality is Our Backbone. Customer-focus is Our Tradition. Flexibility is Our Strength.

Full TimeRemoteTeam 501-1,000Since 2004H1B Sponsor

• Lead efforts in resolving day to day work related issues and problems • Provide statistical expertise for design, analysis and reporting of clinical trials and research projects • Develop and/or review ADaM dataset specifications • Perform statistical analysis as per SAP and address peer/QC review comments and findings • Provide statistical input to Case Report Forms (CRF) design and database/variable structure • Comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions • Plan and carry out professional development activities

Canada
$110K - $160K / year
Everest Clinical Research logo

Senior Biostatistician

Everest Clinical Research

Quality is Our Backbone. Customer-focus is Our Tradition. Flexibility is Our Strength.

Full TimeRemoteTeam 501-1,000Since 2004H1B Sponsor

• Lead efforts in resolving day to day work related issues and problems • Provide statistical expertise for design, analysis and reporting of clinical trials • Develop and/or review ADaM dataset specifications • Perform statistical analysis as per SAP and core results validation • Provide statistical input to CRF design and data validation specification

United Kingdom
Intellect logo

Clinical Provider (Hobart, TAS - Australia)

Intellect

Redefining mental health with personalised end-to-end care for workforces across Asia Pacific.

ContractRemoteTeam 51-200H1B Sponsor

About Intellect At Intellect, we’re a leading global mental health tech company in 100+ markets worldwide. We partner with employers, insurers, and governments to deliver coaching, counselling, and therapy services across Australia. We’re expanding our EAP provider network and hiring coaches, counsellors, and psychologists. Whether you’d like to supplement your private practice or take on a full-time career pathway, Intellect offers flexibility to fit your lifestyle. Why Join Us? - Flexibility in employment models: freelance, contracted, part-time, or full-time — so you can maintain your own private caseload/clients while expanding with Intellect - Competitive compensation & attractive perks - Minimal admin burden — we handle scheduling, billing, client matching - Regular supervision & CPD included - Diverse client base — from local employees to regional/global Fortune 500 companies - Additional opportunities: CISP (Critical Incident Stress Programme), webinars, in-person seminars, clinical leadership What You’ll Do - Provide 1:1 telehealth and/or onsite coaching, counselling, or therapy-style consultations, offering general advice only (not treatment) - Deliver CISP (Critical Incident Stress Programme) virtually or onsite as needed - Facilitate webinars and in-person seminars (optional) - Support employees with wellbeing, stress, and resilience - Collaborate with Intellect’s internal clinical team to improve EAP programs Must Haves  Counsellors & Clinical Psychologists Counsellors: - Master’s in Counselling or Counselling Psychology - Active membership/registration with one of: - ACA (Australian Counselling Association) - PACFA (Psychotherapy & Counselling Federation of Australia) - 1–3 years of supervised counselling experience (internship counts if part of licensure pathway) Clinical Psychologists: - Master’s in Clinical Psychology from an APAC-accredited program - General registration with AHPRA (Psychology Board of Australia) - Area of Practice Endorsement in Clinical Psychology preferred (or in progress via Registrar Program) - 1–3 years of supervised clinical practice Nice to Haves  - Experience working with First Nations / Aboriginal & Torres Strait Islander communities - Background in managerial or leadership support (e.g., coaching managers, HR advisory) - Prior EAP or workplace counselling experience - Additional languages - Flexibility for occasional onsite sessions - Willingness for Police Check and/or Working With Children Check (not mandatory, only if requested by some clients) - Eligibility/willingness to obtain a Medicare provider number (not mandatory, only if required by engagement type) Let’s Talk This is more than a job. It’s your chance to: - Work with a global provider network - Broaden your clientele base beyond local users - Grow your career outside of sessions through research, content, and webinars - Access supervision & CE most EAPs don’t provide If you’re ready to make a meaningful impact and expand your practice with flexibility, we’d love to hear from you.  Apply today and join Intellect in transforming workplace mental health across the country and beyond.

Australia