Project Services Manager - BOL (pRED) Team

PURPOSE

Under general direction, manage all bio sample strategy and laboratory aspects of clinical trial studies for pRED, either global and / or regional studies; serve as a point of escalation for studylevel issues, while ensuring consistency of delivery on a global level. Participate in and support the business development process as required. Provide operational expertise to consistently implement the bio sample strategy for a given clinical study, ensuring timely sample data delivery at optimal quality for the end to end process.

RESPONSIBILITIES

• Study Planning and Protocol Development Phase (Early Engagement phase): provide support to pRED team re samples/assays, logistics, allowing the team to draft/finalize the scope of samples collected and assays required, including identification of any new assays.
• Perform the technical review at project initiation and provide input into project proposals as well as lead discussions around budget implications and changes.
• Oversee the writing of protocol-specific laboratory instruction manuals incorporating third party information and participate in the preparation and maintenance of the Laboratory Specifications Document for each assigned protocol.
• Provide input to site level feasibility and selection in relation to relevant sample collection, processing and shipping requirements.
• Provide input to protocol and informed consent design to ensure logistical feasibility of biological sampling and alignment with appropriate regulatory, legal and ethical guidelines and requirements.
• Perform project management of laboratory aspect of assigned studies and ensure the project is delivered in line with the agreed KPIs.
• Develop start-up plans including but not limited to project monitoring and communication plan including tracking of milestones and timelines, risk management and action logs.
• Supporting operational activities related to PK, PD, Clinical Safety and Biomarker samples. Overseeing the timelines/deliverables for all sample testing. Liaise directly with the contracted laboratory or with an internal Roche contact when Q2 Solutions does not hold the contract with the third party laboratory e.g. for PK and Biomarkers.
• Collaborate with other functional groups within the Q2 Solutions where necessary to provide scientific and technical advice, to support milestone achievement and to manage risks and challenges.
• Lead in the identification and resolution of service level issues, as well as the proactive development of contingency plans to mitigate laboratory risk at the study level.
• Ensure lessons learned are gathered and applied, and applicable improvements included in study design process.
• As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings.
• Provide additional training to sponsor, CRO, and site personnel as required to address study conduct
• Participate in external and internal audits as required.
• To be accountable for ensuring training in sample handling and sample collection and processing reference materials are provided as appropriate for a given clinical study.
• Direct, mentor and assist in training of Bio sample Operations Leads new to the role.
• Be responsible for the accurate and timely forecasting and management of individual study variable costs related to bio sampling, in collaboration with key stakeholders
• Provide regular study level bio sample status updates to the (Study Management team) SMT and key stakeholders as required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Possess strong interpersonal skills for interaction with senior members within sponsor organizations and demonstrated ability to meet deadlines.
• Experience in successfully leading Phase I and II clinical trials.
• Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.
• Demonstrated computer proficiency with Microsoft Office and Q2 Solutions LIMS system. .
• Possess an understanding of medical and clinical research terminology.
• Demonstrated ability to work in a fast-paced, high stress environment.
• Knowledge of Project Management processes and terminology.
• Previous knowledge of Q2 Solutions processes and computer systems is highly desired.
• Good organizational and operational skills
• Good accuracy and attention to detail skills
• Strong written and verbal communication skills including good command of English language