Mgr Clinical Research Services

Spectraforce

Thousand Oaks, California


a month ago

Similar Jobs
Mgr Clinical Research Services
Spectraforce
Thousand Oaks, California

a month ago

Job Description

Job Title: Manager Clinical Research Pharmacy Services
Duration: 1 Year
Location: 100% Remote
 
Purpose:
Support GDO to ensure IP Management processes and the clinical site perspectives are understood and integrated into company’s Clinical Trial design and execution.
Support Clinical Program Operations (CPO), GSO-SM and Global Development Operations (GDO) to develop IP documentation and training and assist with the resolution of IP quality issues.
 
Role description: A global role reporting into Senior Manager, Clinical Research Pharmacy Services supporting IP Management specific deliverables in Clinical Trial Execution.
 
Responsible for:
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’s 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).
 
Basic Qualifications
Must have degree in Pharmacy, 3-5 YOE, 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 working on complex clinical programs in a pharmacy at an investigational site
Experience with drug formulations, sterile product compounding and administration practices
Experience introducing new processes or services
 
Knowledge
Relevant therapeutic area education and training
Relevant therapeutic area experience
Knowledge of ICH/GCP regulations and guidelines
Detailed knowledge of clinical trial operations
Computer and system operation skills
Demonstrated ability to anticipate and resolve problems
Ability to write, communicate and present clearly using scientific and clinical issues terminology
 
Competencies
Demonstrated ability to work independently with minimal supervision
Takes action without relying on unnecessary oversight.
Seeks to understand patient and stakeholder needs and takes steps to resolve them.
Maintains integrity, professional codes of conduct and regulatory requirements.
Exercises appropriate judgment in urgent and non-routine situations.
Considers various inputs, criteria, and trade-offs to arrive at effective decisions and recommendations.
Clear, concise, and professional in communication.
Prioritises quality and patient safety
Excellent organizational and planning skills
Attention to quality and detail
Ability to identify and resolve problems
 
Top 3 Must Have Skill Sets:   
Must have degree in Pharmacy
Must have experience in a clinical setting
Experience as an investigational pharmacist preferred
See basic / preferred qualifications in description**
 
Day to Day 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.
 
Possible Extension: Yes
Red Flags:      
Must have 3-5 YOE of clinical setting experience as a pharmacist
Many short duration assignments
 
Interview Process:     
30 minute initial phone interview/ or teams webex with hiring manager
2nd round- panel interview with Sr Managers and Director
2 presentations- 1 on case presentation based on case study provided and 1 5 minute presentation

Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/hr.