Clinical Supply Project Manager

Who Are We

For nearly 30 years, CalCog has been dedicated to supporting the R&D supply chain. As a global company, our services include clinical packaging design, clinical packaging and labelling, global storage and distribution, commercial and ancillary product procurement, and medical product supply management to support post-trial and early access programs. 

If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.

Position Summary

The Clinical Supply Project Manager plans, implements and coordinates the day-to-day clinical supplies activities for clinical research development programs associated with investigational and marketed drugs. They have direct responsibility for day-to-day project planning and implementation of tasks necessary to ensure the successful completion of protocols. These tasks include building a comprehensive project plan and facilitating the production scheduling, procurement coordination, label design coordination, batch record documentation, project document creations, budget tracking, and client communication

and expectation management.

The Clinical Supply Project Manager will ensure protocol-specific objectives, timelines and budget guidelines are accomplished. If variances occur, he/she will immediately report these to the client and process any necessary change orders or amendments to ensure CalCog is being compensated for work performed. They work closely with client representatives and site management staff to identify and propose solutions and corrective actions to complex clinical supply problems.

Additional responsibilities involve ensuring tasks and activities comply with current Good Manufacturing Practices (cGMPs) and under CalCog Standard Operating Procedures (SOPs), plan improvement implementations related to clinical supply routine functions, interact with other departments to implement planned improvements.

They will be responsible for leading the internal, cross-functional team assigned to each protocol; directs and coordinates the activities of project assigned team members to resolve issues

including, labeling, packaging, distribution of clinical supplies, randomization, and drug accountability.

Organizational Position

The post holder reports directly to the Head of Project Management, but he/she will work closely with the Business Development team, the broader CalCog Commercial team, the CalCog Operations team, and the CalCog QA/QC team. This role requires 2-3 days a week onsite at CalCog's Bastrop, TX facility.

Responsibilities

• Determine scope and operational requirements of the project from the quotation and customer supplied information.
• Hold a kickoff meeting with the sponsor at project initiation to ensure information is provided so that all parties are fully aware of the scope of the project and their responsibilities within the project.
• Work with third parties involved in projects, such as IRT providers, CROs or consultants at project initiation to determine and clearly define CalCog responsibilities within the scope of the project.
• Perform risk assessments at project initiation and continually assess throughout the project.
• Work together with CalCog internal team and customer to prioritize and mitigate any project risks identified.
• Responsible for the building, management, and updating of the comprehensive project plan for each project under his/her management; Identify and include on the plan all critical tasks and inter– dependencies impacting project timelines, including tasks being performed by other facilities.
• Maintain the project plan to always reflect the current status of the tasks associated with the project.
• Responsible for creation of the project documentation and disseminating them in order that all departments and sponsor are aware of agreed responsibilities and project specific requirements.
• Lead the activities of the project team at all stages of the project, coordinating tasks and ensuring completion in line with the timelines agreed on the project plan.
• For any requests for additional services / changes to scope or where a budget has been exhausted, create a change order, and obtain client approval.
• Attend and/or present at off-site customer / investigator meetings or conferences / workshops, as requested, using available opportunities to promote the services of CalCog.
• Manage flow of return CTM and final CTM accountability and destruction.
• Record, collate and report customer specific KPIs, agreeing and implementing performance improvement plans, where necessary.
• Supports Business Development team members with client visits where required.
• Other related duties as assigned by supervisor.

Qualifications, Experience and Skills Required

• Bachelor’s Degree in Biology/Life Sciences or the equivalent combination of education and 5+ years pharmaceutical research experience required.
• Ability to organise, plan and prioritise tasks within a high volume, varied workload.
• Ability to interpret and apply cGMP and GCP knowledge.
• Strong interpersonal skills and the ability to manage, motivate and influence work behaviors.
• Proven experience to manage and organize a team.
• Open-minded, empathic, and able to adapt to different cultures among our international clients, investigators, study coordinators and projects.
• Flexible, enthusiastic, and highly motivated to work in a challenging environment.
• Proficient knowledge of various computer applications- to include Microsoft Office applications (Word, Excel, Outlook).
• Attention to detail and statistical aptitude.

This role may require international travel and coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role.