WeStaffIT, Inc.

"Your IT Staffing Solutions Partner"

senior manager, regulatory sciences (biotech/pharma)

Our biotechnology client has an immediate need for a Sr. Manager, Regulatory Science on a full-time basis in their Los Angeles location.  You will primarily support the US regulatory aspects of regulatory affairs for their lead product, research & summarize regulatory intelligence, provide regulatory input for regulatory submissions and work closely with colleagues to compile & review submissions for completeness and quality.

 

This position may manage employees of the department and is responsible for the performance management and hiring of any employees reporting to this role within that department.

 

Responsibilities:

  • FDA contact for assigned projects.
  • Participates in global regulatory team, study teams, and ad hoc meetings as a regulatory affairs representative.
  • Offer submission strategies and identifies potential regulatory risks.
  • Tactical support for the timely preparation, editing and review of submissions, including Health Authority Meeting Requests & Briefing Documents, IND/CTA amendments, NDAs/NDSs/MAAs and their respective amendments/supplements
  • Support creation of cover letters, forms, and other required documentation for applicable submissions including drafting of proposed US labels.
  • Liaises internally and externally on applicable submission documents including the uploading and routing of documents in EDMS and the review of documents.
  • Assist in the global strategy for potential new markets and regulatory intelligence for indications of interest.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Provide interpretation of new regulations, guidance documents and directives; and advises on impact on internal programs.
  • Compile and maintain global regulatory documentation databases or systems.
  • Archive global submissions and regulatory correspondence.
  • Complete CTA Questionnaires for all studies on monthly basis.
  • Build and maintain spreadsheets that will calculate and organize business metrics as required.
  • Compose or update standard operating procedures, work instructions, or policies as needed.
  • Support Global MAA with Regional Partners
  • Manage ex-US CTAs through local regulatory consultants
  • Excellent listening and communication skills, with an ability to accept direction and feedback

Required Skills:

  • Minimum of Bachelor’s degree
  • Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
  • Had prior US Regulatory Lead, FDA contact, or directly related experience, preferably in the oncology therapeutic area

 

 

Principal Clinical Data Manager

Primary Objective of Position

The Principal Clinical Data Manager, Clinical Data Management, is responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance

Major Duties/Responsibilities

  • Excellent organizational skills and ability to prioritize tasks
  • Must be able to work under tight timelines
  • Possess excellent communication skills
  • Anticipates change and reacts quickly and intelligently to accommodate business needs.

Skills & Abilities

  • Detail oriented and self-motivator
  • Familiarity in Microsoft Office Products
  • Excellent listening and communication skills, with an ability to accept direction and feedback

May involve travel up to 10%

Education & Professional Experience

Required:

  • Bachelor’s Degree in a biological sciences or other medically related areas
  • Minimum of 7 years of data management experience in the biotechnology/pharmaceutical industry
  • Familiarity with data management software (e.g. Medidata, Oracle Clinical)
  • Working knowledge of coding dictionaries – MeDDRA and WHODRUG

Preferred:

  • Knowledge of Oncology clinical trials
  • Nursing background
  • Vendor management experience
  • Familiarity with SAS

Clinical Data Manager

Our Biotechnology client has an immediate need for a Clinical Data Manager to lead studies in the Sleep Medicine and Hematology/Oncology areas. You will be an active member of a multi-disciplinary team to plan and execute Data Management tasks required for phase 1-4 studies. In addition, you will be a part of an R&D Operations group that intends to implement the most up-to-date methods of data-driven trial management and hence has a key role in the organization.

Responsibilities:

  • Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
  • Able to support several clinical studies with minimal guidance
  • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Able to perform a thoroughly detailed review of eCRF data requirements.
  • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
  • Develop data edit check specifications and run data listings as required
  • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
  • Develop the Data Management Plan for a clinical study.
  • Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans,
  • Statistical analysis plans and vendor specifications
  • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
  • Perform reconciliation of header data from external data sources against the clinical database
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Assist in database upgrades/migrations including performing User Acceptance Testing
  • Able to maintain study workbooks and data management files
  • Perform database lock and freeze activities per company SOPs
  • Participate in regular team meetings and provide input when appropriate
  • Provide input into the development of data management SOPs, Work Instructions, and process documents
  • Contribute to a professional working environment including the application of Code of Business Conduct and Ethics
    Assist with the training of new employees and/or contractors

Requirements:

  • BA/BS, preferably in the scientific/healthcare field.
  • At least two years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
  • Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are desirable.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.