Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Clinical Compliance

Expired Job

Inovio Pharmaceuticals, Inc. Plymouth Meeting , PA 19462

Posted 2 months ago

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

Job summary

The Associate Director Clinical Compliance is responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues. This position is also responsible for management and execution of clinical vendor qualification assessments.

Essential job functions and duties

  • Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates

  • Execute strategy for role-based training curriculum, GCP training and Inspection Readiness training for the Clinical organization

  • Oversee and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments

  • Manage and oversee the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure

  • Manage the review of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.

  • Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections

  • Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities

  • Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

  • Plan, assign and direct work; manage, develop and support Clinical Compliance staff

  • Travel up to 20% may be required

Minimum requirements

  • Bachelor degree in scientific/medical/pharmaceutical discipline or equivalent is required.

  • 8 years pharmaceutical industry experience with at least 5 years in compliance, quality, training or related clinical operations function. Prior experience with both clinical auditing and operations is required.

  • Working knowledge of ICH GCP, FDA Regulations and EU Clinical Trial Directives; thorough knowledge of the drug development process. ISO guidelines and device experience a plus.

  • Strong partnering and collaboration skills. Ability to work with different functional areas within the company and accomplish goals in a matrix environment.

  • 5+ years of line management experience, including management, development and mentoring of assigned staff members.

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Data Manager

Inovio Pharmaceuticals, Inc.

Posted 3 days ago

VIEW JOBS 11/9/2018 12:00:00 AM 2019-02-07T00:00 Company Profile Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of cancer immunotherapies and clinical studies, the company is advancing a growing product pipeline. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. For more information, visit www.inovio.com. Job Summary Data Manager will collaborate with biostatistics, programming, clinical development/operations, regulatory affairs and outside vendors. Experience with data management on vaccine, oncology, or infectious disease trials is a plus. * Essential job functions and duties * All aspects of data management (DM) related to assigned projects include: * Assist in Vendor management/oversight * Assist in oversight of Database design * Assist in the review and creation of edit check specifications * Assist in CRF design/review * Review of clinical data for accuracy * Generation of adhoc reports/listings * Assist in creation/review of data management plans * Assist in coordinating activities with statistics and programming for DM deliverables * Assist in User acceptance testing for CDMS and IXRS system as needed * Track quality issues and general data trends * Ensure adequate filing and archiving of relevant data and documentation related to DM * Assist in development of SOPs and work instructions * Work effectively as a team player Additional functions may include: * Assist EDC training for co-workers, site staff, and CRAs * Assist in facilitating interim safety reviews * Other duties as needed * Minimum requirements BA/BS degree * Minimum of 0-5 years of experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting * Self-starter, able to communicate well within a team environment; candidate will be proactive in managing and completing tasks in a timely fashion * Knowledge of Electronic Data Capture (EDC) and related tools and processes, preferred * Knowledge of database design and database concepts, preferred Essential Requirements: * Good verbal and written communication skills as well as interpersonal and organizational skills * Attention to detail, ability to prioritize and handle multiple tasks * Proficiency in MS Office applications * Travel up to 10-15% Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer. Inovio Pharmaceuticals, Inc. Plymouth Meeting PA

Associate Director, Clinical Compliance

Expired Job

Inovio Pharmaceuticals, Inc.