Talent.com
Associate Director, Clinical Data Management
Associate Director, Clinical Data ManagementExelixis • Alameda, CA, United States
Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

Exelixis • Alameda, CA, United States
30+ days ago
Job type
  • Full-time
Job description

SUMMARY / JOB PURPOSE :

Oversees, develops and manages clinical data management activities while collaborating and coordinating with other departments. Oversees the evaluation, integration and implementation of new clinical systems and technologies for clinical trial management activities including electronic data capture and documentation systems.

Essential Duties And Responsibilities :

  • Provides a high level of expertise in data management to support clinical studies, including areas such as : Case Report Form (CRF) design, database design, data management plans, edit checks / quality review plans, query resolution processes, data transfers, SAE / AE reconciliation, thesaurus coding processes, and database lock.
  • Manages time and resource constraints across multiple projects.
  • Develops and implement new or improved processes for data management.
  • Effectively manages Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget.
  • Participates in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
  • Provides oversight on quality and timeliness of task completion by direct reports.
  • Develops and implement training curriculum for data management activities and principles as required.

Supervisory Responsibilities :

  • Directly supervises employees
  • May Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.
  • EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

    Education / Experience :

  • BS / BA degree in related discipline and a minimum of 11 years of related experience; or,
  • MS / MA degree in related discipline and a minimum of 9 years of related experience; or,
  • PhD in related discipline and a minimum of 5 years of related experience, or;
  • Equivalent combination of education and experience.
  • May require certification in assigned area.
  • Experience / The Ideal for Successful Entry into Job :

  • Typically requires a minimum of 14 years of related experience or the equivalent combination of experience and education / training.
  • Experience in Biotech / Pharmaceutical industry preferred.
  • Demonstrated experience leading data management teams is required.
  • Experience participating in regulatory submissions and inspections is required
  • A minimum of 7 years of line management experience is required
  • Knowledge / Skills :

  • Has extensive experience in relevant industry / profession.
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
  • Develops technical and / or business solutions to complex problems.
  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
  • Guides the successful completion of major programs, projects and / or functions.
  • Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
  • Interprets, executes and recommends modifications to companywide policies and / or divisional programs. May establish organizational policies in a major segment of the company.
  • Has complete understanding and wide application of technical principles, theories, concepts and techniques.
  • Has extensive knowledge of other related disciplines.
  • Applies strong analytical and business communication skills.
  • Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
  • Knowledge of Good Clinical Practices (GCP) is essential.
  • Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
  • JOB COMPLEXITY :

  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
  • If in a leadership role, works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
  • If in a leadership role, participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
  • Ensures budgets and schedules meet corporate requirements.
  • Creates formal networks involving coordination among groups. Regularly interacts with executives and / or major customers.
  • #LI-JP1

    If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

    Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $176,500 - $250,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

    In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

    DISCLAIMER

    The preceding job 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 the job.

    We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

    Create a job alert for this search

    Associate Director Clinical Data Management • Alameda, CA, United States

    Related jobs
    Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness

    Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness

    Gilead Sciences • San Francisco, CA, United States
    Full-time
    Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness.At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases suc...Show more
    Last updated: 13 days ago • Promoted
    Clinical Research Associate II - Temporary

    Clinical Research Associate II - Temporary

    Bio-Rad Laboratories • Hercules, CA, United States
    Full-time
    As a CRA at Bio-Rad, you will play a vital role in ensuring the successful conduct of clinical trials from initiation to closeout. You will collaborate with numerous investigators, study coordinator...Show more
    Last updated: 29 days ago • Promoted
    Visionary Associate Lab Director, Physical Sciences

    Visionary Associate Lab Director, Physical Sciences

    Lawrence Berkeley National Laboratory • Berkeley, CA, United States
    Full-time
    A prestigious research laboratory in Berkeley, California is seeking an experienced Associate Laboratory Director for the Physical Sciences Area. This leadership role involves strategic planning, or...Show more
    Last updated: 6 days ago • Promoted
    Project Director

    Project Director

    Arcadia Science • Emeryville, CA, United States
    Full-time
    We are Arcadia Science, an evolutionary biology company founded and led by scientists.Our mission is to turn natural innovations into real-world solutions by developing systematic and quantitative ...Show more
    Last updated: 30+ days ago • Promoted
    Memory Care Executive Director - Lead with Impact

    Memory Care Executive Director - Lead with Impact

    Silverado Senior Living Management Inc. • Berkeley, CA, United States
    Full-time
    A leading memory care provider in California is seeking an Administrator to lead their Berkeley Community.The ideal candidate will have a solid background in healthcare leadership, compliance knowl...Show more
    Last updated: 1 day ago • Promoted
    Associate Director, Clinical Data Management

    Associate Director, Clinical Data Management

    Exelixis • Alameda, CA, United States
    Full-time
    Oversees, develops and manages clinical data management activities while collaborating and coordinating with other departments. Oversees the evaluation, integration and implementation of new clinica...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director Clinical Operations

    Associate Director Clinical Operations

    Meet Life Sciences • San Francisco, CA, United States
    Full-time
    We\'re supporting a rapidly growing biotech company in the Bay Area that\u2019s advancing a high-impact pipeline in the neurology and immunology space. This is a full-time, hybrid role based in the....Show more
    Last updated: 10 days ago • Promoted
    (Associate) Director, Statistical Programming

    (Associate) Director, Statistical Programming

    Proclinical Staffing • San Francisco, CA, United States
    Permanent
    Associate) Director, Statistical Programming – Permanent – San Francisco Bay Area.Proclinical is seeking an (Associate) Director, Statistical Programming for a rapidly growing biotechnology company...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director, Program Management

    Associate Director, Program Management

    Klein Hersh International • San Francisco, CA, United States
    Full-time
    Our client is seeking an Associate Director, Project Management to join the Project Management team responsible for advancing exciting drug candidates into the clinic to treat diseases with high un...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director, Statistical Programming

    Associate Director, Statistical Programming

    Corcept Therapeutics • Redwood City, CA, United States
    Full-time
    Associate Director, Statistical Programming.Redwood City, California, United States.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortis...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Marketing Associate Director (Provider Channel) #4424

    Clinical Marketing Associate Director (Provider Channel) #4424

    Futureshaper.com • Menlo Park, CA, United States
    Full-time
    Our mission is to detect cancer early, when it can be cured.We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective tech...Show more
    Last updated: 23 days ago • Promoted
    Director - Data & AI

    Director - Data & AI

    Grocery Outlet • Emeryville, CA, United States
    Full-time
    To be the first choice for bargain-minded consumers in the U.Achievement, Diversity, Entrepreneurship, Family, Fun, Integrity & Service. Our BT team's mission is to push the boundaries of technology...Show more
    Last updated: 19 days ago • Promoted
    Clinical Success Director - AI Healthcare Platform

    Clinical Success Director - AI Healthcare Platform

    Abridge • San Francisco, CA, United States
    Full-time
    A healthcare technology company is seeking a Clinical Success Director to enhance clinician experiences with their AI platform. You will provide training, manage relationships, and recommend product...Show more
    Last updated: 4 days ago • Promoted
    Associate Director, Data & Analytics

    Associate Director, Data & Analytics

    BridgeBio • San Francisco, CA, United States
    Full-time
    When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement. In 2015, we pioneered a “moneyball for biotech” app...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Director (LCSW, LMFT) - Mobile Crisis Response Team

    Clinical Director (LCSW, LMFT) - Mobile Crisis Response Team

    Telecare Corporation • San Mateo, CA, United States
    Full-time
    Telecare's mission is to deliver excellent and effective behavioral health services that engage individuals with complex needs in recovering their health, hopes, and dreams.Telecare continues to ad...Show more
    Last updated: 26 days ago • Promoted
    Associate Director, Biosample Operations

    Associate Director, Biosample Operations

    Jade Biosciences • San Francisco, CA, United States
    Temporary
    Associate Director, Biosample Operations.Be among the first 25 applicants.Jade Biosciences is focused on developing innovative, best‑in‑class therapies to address critical unmet needs in autoimmune...Show more
    Last updated: 14 days ago • Promoted
    Associate Director / Director, In Vivo Pharmacology

    Associate Director / Director, In Vivo Pharmacology

    ImmunEdge, Inc • Redwood City, CA, US
    Full-time
    Quick Apply
    Redwood City Company Overview : ImmunEdge is a biopharmaceutical company committed to developing novel therapeutics for patients with serious or life-threatening diseases.With a highly experienced ...Show more
    Last updated: 30+ days ago
    Associate Medical Director / Medical Director, Endocrinology / Metabolism

    Associate Medical Director / Medical Director, Endocrinology / Metabolism

    Corcept Therapeutics Inc • Redwood City, CA, United States
    Full-time
    Associate Medical Director / Medical Director, Endocrinology / Metabolism.Redwood City, California, United States.Corcept is leading the way in the research and development of cortisol modulators, mole...Show more
    Last updated: 6 days ago • Promoted