Regulatory Affairs and or Clinical Operations Manager - Biotech Resume
Regulatory Affairs and or Clinical Operations Manager - Biotech Resume
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Regulatory Affairs and/or Clinical Operations Manager Resume

Desired Industry: Biotech SpiderID: 32232
Desired Job Location: San Diego, California Date Posted: 1/1/2010
Type of Position: Full-Time Permanent Availability Date: 01/11/2010
Desired Wage: Negotiable
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Bachelors Willing to Relocate: Yes

Regulatory Affairs and/or Clinical Operations Manager with substantial expertise in Project Management, Quality and Administrative Management. Knowledge of FDA, ICH, GCP and GMP guidelines. Therapeutic areas of experience in Oncology, Infectious Disease (HIV, Hepatitis), Gene Therapy, CNS and Inflammatory Disease (Crohn's, Ulcerative Colitis, Rheumatoid Arthritis, Fibromyalgia, Psoriasis). Proficient in the preparation, format and compilation of complex regulatory submissions and Phases I — III study initiation through closeout documentation. Excellent organizational, management, leadership and interpersonal skills, including leading and facilitating work teams through constructive, encouraging verbal, written and audiovisual communication, team building and cross-functional relationships. Motivates, trains, and develops regulatory and clinical team expertise, manages RAAs, CTAs, and Administrative personnel to ensure efficient, quality and regulatory compliant day-to-day operational support. Ability to plan, prioritize and manage multiple assignments concurrently with exceptional attention to detail and meticulous follow-through, quality and project focus. Self-motivated and retains a positive attitude under pressure. Grasps concepts easily and uses creativity, judgment and decision making skills to resolve unforeseen challenges.


Currently in transition and actively pursuing full-time permanent opportunities in Regulatory Affairs and/or Clinical Operations/Project Management. Providing Regulatory Affairs/Quality and Clinical Operations expertise on a part-time, voluntary basis for Life Sciences Information Technology Global Institute (LSIT) to assist in their critical mission to develop Good Informatics Practices (GIP) guidelines for both the Life Sciences and Healthcare industries.

Senior Regulatory Affairs and Clinical Operations Associate

Create, format and prepare numerous regulatory submissions, i.e., INDs, IND Amendments, Drug Master Files, CTDs, Annual Reports, Protocols, Investigator’s Brochures, etc. Design and create all clinical study initiation through closeout documentation such as eCRFs, CRF Completion Guidelines, Investigator Regulatory Binders, Site Reference Manuals and Monitoring Reports. Coordinate initiation visit with document approval and drug shipment, review and track study monitoring and termination reports from CRAs/CROs to confirm quality standards, consistency and expectations are met through understanding of the processes associated with delivery of quality data in order to ensure best practices for data retrieval and review. Serve as key contact for clinical sites and manage competing clinical study team requests. Ensure audit-ready condition of paper and electronic master clinical trial documentation. Work independently or in a team environment on multiple studies simultaneously.

ELAN PHARMACEUTICALS, INC., San Diego, CA 3/2003 – 6/2004
Senior Clinical Operations Associate

Implemented and managed a new Clinical Operations Department and medical writing QC activities. Developed global, cross-functional medical writing QC standards to ensure consistent, high quality document production. Created training materials, guidelines, tools and checklists for authors, reviewers and approvers. Established QC standards with clear deliverables for contractors. Conducted document QC checks of clinical and regulatory documents, including Clinical Study Reports, Protocols and Investigator’s Brochures. Established clinical study file standards, facilitated file maintenance, including training and document compliance checks.

Senior Regulatory Affairs and Clinical Operations Associate

Organized, coordinated and prepared various regulatory submissions such as INDs, Master Files, Protocols, Investigator’s Brochures, Annual Reports and all clinical study initiation documentation including eCRFs, CRF Completion Guidelines, Investigator Regulatory Binders and Site Reference Manuals. Created complex illustrations designated for incorporation into numerous submissions for clinical and commercial applications, and various other types of documentation and product development presentations.

ISIS PHARMACEUTICALS, INC., Carlsbad, CA 5/1999 – 6/2001
Project Team Coordinator, Clinical Operations/Project Management

Facilitated and effectively managed the initiation through closeout activities and logistical aspects of multiple Phase I, II & III, U.S. and European Oncology, Hepatitis and Inflammatory Disease clinical research studies according to GCP and relevant SOPs; including Protocol review, eCRF, AE, SAE, Monitoring Reports, and regulatory document creation and collection. Acted as Assistant Project Manager/Pivotal Point of Contact for the Clinical Trial Teams including CRAs, Investigators, and Investigative Site Coordinators for designated project communication, correspondence and associated documentation. Managed functional study teams to ensure clear communication, expectations and deliverables. Management of clinical resources, risks, budgets and schedules to implement resource allocation consistent with project requirements, involving delegation of activities in accordance with individual skill sets and capabilities, to ensure maximum efficiency and quality of project success. Attended Regional CRA, Investigator and CRO meetings, and assisted in the creation/writing of site advertisements for various studies. Performed administrative tasks as needed to support team members with clinical trial execution.

Proactively identified exigent issues, anticipated project requirements and instituted appropriate actions to ensure milestone and budget commitments were met, including assessment of workload, resource allocation, and staffing needs of the group, plus training and supervision of support personnel. Facilitated regular review meetings to discuss constructive problem resolution of study specific issues, utilizing necessary resources from all relevant internal departments. Developed, introduced and supervised an audit-ready Master document control system for Clinical and Regulatory, including a working Data Management file system for all clinical research subject files in accordance with ICH guidelines and SOPs.

Manager, Corporate Quality Systems and Senior Regulatory Affairs/Clinical Operations Associate

Utilized expert computer knowledge in the preparation and review of complex regulatory submissions, including INDs, FDA Product Approval applications, Response Letters, Protocols, Investigator’s Brochures, Master Files, Annual Reports, CRF design, and clinical data dissemination and presentation. Developed and implemented innovative standardized work processes, systems, tools and methodologies that improved quality, productivity and efficiency resulting in a 73% increase in productivity; reallocation of resources to deficit areas, a 39% decrease in office supplies, and substantial monetary savings. Analyzed knowledge and detailed understanding of underlying technologies in Regulatory and Clinical departments to effectively establish, lead implementation and ongoing educational training to enhance management of multiple, simultaneous programs and projects of varying scope and size. Supervised paraprofessional and supportive functions. Conducted quality evaluation of client and corporate documentation, including compilation of information for audits and inspections. Designed, administered and maintained a centralized document control tracking system for the preparation, approval, distribution and revision of Clinical Department SOPs and associated documentation, in accordance with GCP. Additionally, identified the need for, and implemented a company-wide document control and retrieval system for all client and non-client related documentation.

CHIRON TECHNOLOGIES (Formerly VIAGENE, INC.), San Diego, CA 4/1992 – 3/1997
Regulatory Affairs and Clinical Operations Associate

Designed and produced over 2,000 eCRFs for clinical trials. Disseminated clinical data into graph format for incorporation into regulatory submissions, Investigator’s Brochures, Protocols and presentations. Responsible for the creation, editing, management and maintenance of all Clinical and Regulatory, QA/QC, Manufacturing and Validation department master documentation, including but not limited to, regulatory submissions, Batch Records, SOPs, STMs and Validation Protocols compliant with GMP. Initiated and provided personalized software training programs in conjunction with administering a “Software Help Desk” hotline for all personnel throughout the company. Provided graphing and graphic illustration training and support to all scientific and business development staff to be incorporated into scientific papers and presentations. Trained and supervised CTAs, permanent and temporary support personnel in Regulatory Affairs, Clinical Operations, Administration, R&D, Manufacturing, QA/QC, Business Development and Intellectual Property departments.

Rochdale College of Technology, Rochdale, England

Bachelor’s Degree, Business Administration and Economics


Expert level certification (Instructor) in Mac and PC based software applications — Microsoft Word, Excel, PowerPoint, Project, Canvas, PageMaker, MacDraw, Deltagraph, Cricketgraph, FileMaker Pro., Acrobat and various other applications.

Zenger Miller Frontline Leadership Certification

Reuters Insight Expert – Certified Member

Gerson Lehrman Group Healthcare Council — Certified Member

Life Science Information Technology Global Institute – Certified Member


INDs, Annual Reports, Drug Master Files, CTDs, IBs, Protocols, FDA, ICH, GCP, GMP regulations and guidelines. Extensive experience in project planning, coordination and management of both the regulatory submission process and clinical operations/logistical aspects of multi-center clinical trials in Phases I – III, high ethical and quality standards and integrity. PI regulatory and site reference materials, resource planning, document control/master files implementation, excellent computer expertise, server architecture, AEs/SAEs, SOPs, query resolution, drug supply, budgets, eCRFs, logs, audits, QA/QC, vendor management, training/mentoring, outstanding organizational abilities and excellent communicator. Ability to work extremely well in both team-oriented and self-directed environments.

Additional Information:

* Created, formatted, edited and published multiple INDs, IND Amendments, Drug Master Files, CTDs, Investigator’s Brochures, Protocols, Protocol Amendments, Informed Consents, Clinical Data Interim Reports, NIH and FDA Advisory Committee (including RAC) submissions and Scientific Journal Publications, in addition to providing regulatory guidance to project teams and individuals as required.

* Received letter of recognition and commendation from the FDA for setting the formatting, and quality precedence for INDs, Master Files, RAC, Protocols, and Investigator’s Brochures for submission and review by the Agency.

* Developed, administered and managed numerous paper and electronic trial master files incorporating document control central tracking systems for Regulatory, Clinical, QA/QC and Manufacturing departments. Conducted internal audits of departmental trial master files and document control systems pursuant to providing appropriate training. Coordinated and managed all document change requests (DCRs) in accordance with FDA requirements. Awarded “Outstanding Achievement Award” for the creation and maintenance of GCP, GLP and GMP multi-trial master filing and document control systems for review and audit inspection approval by the Agency.

* Formulated and promoted harmonization endeavors across all project teams. Introduced in-house electronic creation, production and maintenance of all eCRFs and customized clinical study materials, including Investigator Regulatory Binders and Site Reference Manuals in support of regulatory filings. This challenge resulted in initiating three studies concurrently within 90 days (one Phase I and two Phase IIb domestic and international studies), which consisted of approximately 30+ sites per study with a projected enrollment of 25+ patients per site, resulting in substantial savings and efficiencies.

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