Mgr Clinical Research Pharmacy Services at Randstad USA

job summary:

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location: Newbury Park, California
job type: Contract
salary: $75 - 85 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• Supporting the execution of the strategic direction of CRPS to ensure safe, high quality and compliant Clinical Trial execution.
• Ensuring quality within studies for IP management processes, documentation and training
• Advising and supporting key stakeholders to ensure IP Management practices are followed at global sites in line with GCP, ensuring patient safety and data integrity.
• Advising key stakeholders on clinical site practices/perspectives to safely incorporate these practices into clinical trial design.
• Identifying and mitigating Risk for IP management related activities within individual Clinical Trial design and execution as well as across programs and processes.

Product Activities

• Develop a strong working relationship with CPO and GSO to provide IP Management support to individually assigned programs
• Pro-actively identify Risks and site challenges related to the clinical preparation, labeling, packaging and administration of IP and identify mitigations or raise issues to the appropriate team(s) within Company for analysis and mitigation.
• Investigate potential IP risks and dosing deviations identified at clinical sites and assist CRA/study teams with resolution and action plans.
• Author IP related documentation (e.g. IPPA, Dose Preparation Worksheets and Training Materials) as required for study support and delivery.
• Assist in developing training tools for clinical sites for studies with complex dosing regimens and support delivery of site training where required.
• Act as the primary point of contact on behalf of Company for study related IP Management questions and support site challenges seen with IP administration, formulation preparation, labelling and/or packaging.
• Provide input and support into the design of IP sections of study protocols.
• Provide input and feedback on drug packaging and labelling proposals for clinical studies.
• Pro-actively explore dosing deviations and root causes to identify risk indicators and mitigation plans .
• Respond to audit findings related to IP dosing.

Other Activities

• Ensure consistency within CRPS team and processes.
• Participate as an active member of Clinical Drug Supply & Investigational Product (CDS&IP) CTGN.
• Support functional and departmental continuous improvement initiatives and represent CRPS in supporting these.
• Assist in the development and implementation of preventive actions and process improvement initiatives related to Investigational Product (IP) Management.
• Support internal stakeholders & networks to promote greater cross functional understanding and insight into clinical IP needs, IP presentation and preparation challenges.
• Support the development of training tools as required by Company and site personnel.
• Collaborate with and support non-R&D functions (including Process Development and Quality to ensure appropriate data is generated to support study design) as appropriate
• Collaborate with GDO stakeholders in responding to IP related audit/inspection queries
• Act as a knowledge source for other members of the team and as a representative for CRPS external groups and forums (where assigned).

 
qualifications:

Basic Qualifications

• Must have degree in Pharmacy
• 3-5 Years of experience
• BS or PharmD

Preferred Qualifications

• PharmD or equivalent degree or Nursing degree
• Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech or pharmaceutical company
• Practical experience in a clinical research setting