Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update : Peregrine : 2 new ... the grass can wait, some nice info in these new job titles

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Associate Director/Director, Regulatory Affairs Reg Affairs Tustin, CA 07-Oct-2014 (PST) Full Time

Clinical Data Manager Clinical Affairs Tustin, CA 21-Sep-2014 (PST) Full Time

Clinical Trial Liaison Clinical OPS Tustin, CA 18-Oct-2014 (PST) Full Time -New!

Clinical Trial Manager/Senior Manager Clinical OPS Tustin, CA 11-Sep-2014 (PST) Full Time

Laboratory Assistant Lab OPS Tustin, CA 28-Sep-2014 (PST) Full Time

Manager, Data Governance Information Technology Tustin, CA 18-Oct-2014 (PST) Full Time -New!

Manufacturing Associate - Downstream Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Manufacturing Associate/Senior Associate Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Research Associate, Process Sciences Process Sciences Tustin, CA 24-Sep-2014 (PST) Full Time

Sr. Manager, Clinical Quality Assurance Quality Tustin, CA 12-Oct-2014 (PST) Full Time - New!

Sr. Regulatory Publishing Specialist Reg Affairs Tustin, CA 01-Sep-2014 (PST) Full Time -Filled/Removed

Sr. Research Scientist - Pharmacology Pre-Clinical Tustin, CA 05-Oct-2014 (PST) Full Time

http://peregrineinc.applicantpro.com/jobs/

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Clinical Trial Liaison

Date: Posted 19-Aug-2014, Closing 18-Oct-2014 (PST)

Department: Clinical OPS

Location: Tustin, CA

Employment Type: Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical affairs expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.

SUMMARY

The Clinical Trial Liaison (CTL) will be responsible for developing relationships with clinical trial investigators and research site staff and provide support to sites participating in Peregrine clinical trials. The primary responsibility will be to identify and execute plans to reduce site barriers to patient enrollment and recommend either custom or study-wide solutions to the institution.

ESSENTIAL DUTIES AND RESPONSIBILITIES


Develop, maintain, manage and link relationships across the site to increase awareness of the clinical trial to maximize their success in reaching their enrollment goals.

Understand the scientific basis of assigned clinical trials and be able to communicate the scientific basis of the trials to other team members, investigators and site staff.

Create materials for trial awareness and patient recruitment and any educational materials to effectively communicate the science behind the clinical trial.

Responsible for developing and executing site engagement and patient enrollment plans for multiple cancer clinical trials.

Identify effective prescreening strategies for each trial and recommend improvements.

Provide detailed reports of interactions with investigators and site staff

Attend scientific meetings to make contacts, evaluate the field and obtain ideas for improvements in trial design and conduct, trial awareness and patient recruitment/retention initiatives.

Interact with advocacy groups to increase the awareness and understanding of opportunities for patients to be informed of treatment options in clinical trials.

Assist in identifying trial specific issues and opportunities for developing solutions. Helping increase study accrual will be paramount.

Provide education and mentoring to other CTLs.

QUALIFICATIONS

A BA/BS, RN, with 5+ years of relevant clinical research or medical affairs experience.
Knowledge of and relationships with key opinion leaders and research community is preferred.
Experience collaborating with medical staff in a hospital-based clinical trial is preferred.
Approximately 30 – 50% domestic and international travel is required.

Equal Opportunity/Affirmative Action Employer

Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.


https://peregrineinc.applicantpro.com/jobs/l/129563.html

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Manager, Data Governance

Date: Posted 19-Aug-2014, Closing 18-Oct-2014 (PST)

Department: Information Technology

Location: Tustin, CA

Employment Type: Full Time

Peregrine Pharmaceuticals, on the list of Deloitte & Touche's 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on data management expertise and proven technical abilities in the pharmaceutical industry. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab, which has been given a fast-track designation by the FDA.

If you meet the following criteria we encourage you to apply to become part of our successful team:

SUMMARY

As the Data Governance Manager, your primary duties are to develop, implement and manage enterprise data governance processes, standards and policies company-wide. Establishes the long term strategy concerning information governance for the company to meet compliance requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Define data governance strategy and oversee data governance activities across the organization.
Define, execute, and implement data quality improvement projects.
Participate in the development and presentation of plans and strategies to leadership to gain their support and concurrence.
Facilitate the creation and ownership of Enterprise Data Governance processes according to Industry Best Practices. (e.g., assess current state, identify source of truth, identify Data Providers, Data Custodians, Data Consumers, etc.)
Responsible for working with business functions to define and communicate data usage and standards, policies and procedures for the organization to ensure a common business vocabulary, consistent information and ability to leverage data cross- functionally.
Establish and partner with cross functional data stewards (technical and business) and recommend solutions to resolve issues in data policies, data definitions, data usage, data quality and metrics.
Meet with stakeholders to review data quality performance reports. Develop, analyze and maintain metrics for measuring adherence and improvement. Understand data quality issues and create action plans to resolve.
Work with solution architects to identify appropriate data source and standards for related projects.
Establish and maintain guidelines for Data Sharing and Custodial agreements. (i.e., requirements, frequency, type, etc.)
Leads the creation, implementation, communication and on-going support of data standards and processes. Oversee data modeling activity including data model documentation and metadata.

QUALIFICATIONS

Bachelor's Degree in Business, Computer Science, or four-year related degree, and/or equivalent work related experience.
5+ years in data governance activities and implementing best practices
5+ years in data related activities (conversions, integration, etc.)
3+ years in establishing and managing Master Data Management processes
Minimum 2 years managing direct reports
Strong management and leadership skills with a proactive participative management style
Strong oral and written communication skills, including facilitation of groups toward deliverables
Strong analytical and problem-solving skills
Strong interpersonal, communication, leadership, presentation and negotiating skills
Excellent written and verbal communication skills
Experience managing people and projects
Knowledge of capacity planning and able to formulate scope and scale of project
Proactive in managing issues and problems, comfortable with ambiguity
Skilled at tackling unusual and complex challenges, can guide and advise others
Willingness and ability to share knowledge
Ability to be effective in politically sensitive, high profile projects
Integrity and high ethical standards
Proactive; works independently
Attention to detail
Positive attitude with co-workers and clients

CAREER PATH CORE COMPETENCIES

Communication

Promotes active listening with team members.
Contributes appropriately to conversations.
Accurately prepares written business correspondence that is coherent, grammatically correct, effective, professional and engaging.

PROFESSIONAL QUALITIES

Leadership

Follows through with commitments and fosters mutual trust with fellow Innovators.
Assumes additional responsibility without being asked
Encourages fellow team members to make innovative contributions and embrace new ideas.

Teamwork

Proactively initiates, develops, and maintains effective working relationships with team members.
Recognizes the strengths and weaknesses of each team member.
Demonstrates the ability to cooperate with a variety of people and achieve results.

Client Management

Anticipates internal client needs before they arise and presents solutions to company project management that encompass issues at hand.
Understands expectations that were set with internal clients and recognizes when issues/events may affect delivery.

ORGANIZATIONAL RESPONSIBILITIES

Innovator Development

Proactively seeks opportunities to broaden and deepen knowledge base and proficiencies.
Shares acquired skills with team members through formal and informal channels.
Encourages more junior Innovators to take responsibility for their development within the company.

Internal Operations

Actively contributes to internal programs.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.


https://peregrineinc.applicantpro.com/jobs/l/129650.html