Associate Director, Clinical Sample Project Manager

1 month ago

New Haven, United States Alexion Pharmaceuticals, Inc. Full time

This is what you will do:

You will be a key member of the Clinical Trial Teams to which you are assigned, ensuring that all clinical samples required within the protocols are collected, shipped, analyzed and stored, with high quality and compliance. As a result of your expertise and efforts we will optimize the use of our clinical trials samples to meet protocol requirements, deliver on our promise to our rare disease patients and advance our science by ensuring our scientists have timely access to all available samples to answer new research questions.

You will lead all aspects of clinical sample life-cycle management within ARDU and across external labs and third-party vendors for the clinical trials to which you are assigned. To do so, you will partner with Clinical Operations, Data Management, Clinical Development and multiple members of the Research team to build, implement and manage the end-to-end clinical biospecimen logistics both globally and locally, including oversight of lab vendor setup, tracking, collection materials and laboratory operational plans.

The role requires a combination of scientific and project management expertise with excellent attention to detail.

You will be responsible for:

* Manage clinical samples from multiple global clinical trials and maintain sample chain-of-custody in a GxP-compliant setting
* Accountable for clinical sample logistics planning and coordination with Clinical Operations, clinical sites, external labs, vendors, and couriers to define sample processing and movement timelines needed for sample testing and transfer.
* Coordinate all operational activities required to ensure high quality sample processing, shipping, receiving, and storage of biological research samples
* Collaborate with Clinical Operations, Data Management, Biostatistics, and vendors for data transfer and analysis need
* Potential direct contact to CRA or Project managers
* Input to kit design, sample processing, collection storage and shipping
* Establish overall clinical lab sample accountability strategy across studies
* Tracking lessons learned and apply them across trials for consistency and continuous improvement activities
* Contribute to clinical lab training materials & review of laboratory manuals
* Support virtual or onsite training meetings
* Support communications and build relationships with key stakeholders including CROs, vendors and external collaborators
* Ensures completion, deployment and accuracy of the Clinical Sample Management Plan, or equivalent
* Utilizes tracking systems to report progress, address issues and resolution.
* Represent sample operations at meetings to ensure deliverables related to clinical samples are met.
* Responsible for innovative sample management process improvement.
* Liaise with Data Management, Clinical Operations, and Translational Research to resolve research sample related data reconciliation, and sample related issues at sites or analysis labs
* Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH/GCP, and local regulations.
* Assist with tracking appropriate metrics
* Support Health Authority inspections as needed

You will need to have:

* Minimum of 8+ years of biopharmaceutical R&D experience in drug development and participation in projects involving vendors and cross-functional teams, or equivalent experience.
* Direct experience with clinical sample management and/or clinical trial management
* Knowledge of GCP requirements
* Ability to work effectively in a fast-paced environment to meet deadlines with a can-do attitude
* Excellent communication and organizational skills, along with problem solving and conflict resolution
* Proficiency in MS Office (i.e. Word, Excel, PowerPoint), Adobe Acrobat and SmartSheet

We would prefer for you to have:

* A degree in life sciences ( e.g. BSc, MSc) or regulatory compliance.
* Experience in implementing and using sample management/tracking systems, i.e. Laboratory Information Management System (LIMS)
* Knowledge of GLP requirements
* Experience with rare disease clinical trials
* Project management and/or Lean Six-sigma training

Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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