Manager Clinical Research Pharmacy Services

Purpose:

• Support GDO to ensure IP Management processes and the clinical site perspectives are understood and integrated into Company 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.

Key Skills:

• Must have degree in Pharmacy
• Must have experience in a clinical setting
• Experience as an investigational pharmacist preferred

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 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 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 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