Bay Area Archives | WeStaffIT, Inc.

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

Clinical Data Manager-CONTRACT

THIS IS A CONTRACT ROLE THAT REQUIRES YOU TO BE ONSITE. NO REMOTE OR TELECOMMUTING

W2 OR CORP TO CORP

YOU CAN WORK OUT OF THE CLIENTS LA OFFICE(ZIP CODE 90024) OR THEIR OFFICES IN SOUTH SAN FRANCISCO (ZIP CODE 94080)

Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for 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.

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. Able to perform a thoroughly detailed review of data requirements.

Interact with CRAs, programmers, study managers and statisticians.

Develop data edit check specifications and run data listings as

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 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

Assist with the training of new employees and/or contractors

Requirements:

BA/BS, preferably in the scientific/healthcare field.

At least five – seven years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment

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 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.

Manager Clinical Operations (Finance)-South San Francisco, CA.

The Manager of Clinical Operations (Finance) is accountable for successful execution of business operations processes within the Clinical Operations department including, but not limited to, proposal budget review and negotiation, oversight of contract and budget development for new projects, management of contract amendments, and budget forecasting. Proactively identifies and resolves business operations issues and participates in process development and improvement initiatives as required.
Major Duties/Responsibilities
1. Assists the Director of Clinical Operations (Finance) with the financial management of business operations within the Clinical Operations department to meet department and company-level goals.
2. Provides timely and accurate input to clinical development plans including forecasting of timelines, estimation of resources, and program level budget.
3. Assists Clinical Trial Managers with preparation of Requests-for-Proposal (RFPs) to support vendor selection for new project efforts within Clinical Operations.
4. Develops contract text and budget through negotiation with Clinical Operations vendors for new contracts and contract amendments.
5. Identifies contractual and financial risks to clinical development projects; proactively creates and manages mitigation strategies.
6. Maintains active collaboration with Clinical Trial Mangers regarding the status of their contracts.
7. Maintains project-level budget forecasting tools. Assists Director of Clinical Operations (Finance) with department-level budget forecast input to Corporate Finance.
8. Initiates frequent cross-functional interactions with internal and external personnel (e.g. Accounting, Finance, Quality Assurance, Vendors) and collaborates effectively to achieve desired outcomes.
9. Ensures all aspects of responsibilities are executed in compliance with international GCP guidelines and regulations and company SOPs; Ensures audit-ready condition of clinical trial documentation;
10. Requires excellent communication and organizational skills, along with a strong attention to detail, problem solving, conflict resolution, and collaboration skills.
Physical Demands
The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.
Travel may be required (up to 10%)
Education & Professional Experience
Required:
 Bachelor’s degree or equivalent combination of education/experience in business administration, finance, science or health-related field required
 Minimum of 5 years of clinical trial exposure in Pharmaceutical, Biotech or CRO company required
 Strong understanding of GCP, ICH, and knowledge of regulatory requirements
Preferred:
 Advanced degree in science or business
 Experience with clinical research site and/or vendor contract development
 Experience with development and review of budgets for clinical trial activities
 Oncology experience