Senior Clinical Trial Manager

JOB DESCRIPTION:

At Blue Earth Diagnostics, which is part of the Bracco Group, our mission is to transform the clinical management of patients with cancer by developing innovative molecular imaging technologies. Our team is made up of industry leaders in the field of radiopharmaceutical development and commercialization. Blue Earth Diagnostics is a dynamic and growing company with an approved product already on the market in the USA and in Europe, and a development pipeline of diagnostic radiopharmaceuticals.

The Senior Clinical Trial Manager (SCTM), is responsible for the management of all aspects of Clinical Trial activities on one or more assigned Clinical Trials. This includes the efficient execution of BED sponsored clinical trials in overall compliance with Good Clinical Practice (GCP), Country Regulations and company Standard Operating Procedures (SOP’s), according to time and budget.

Responsibilities

• In accordance with Blue Earth SOPs: effectively plan, implement and monitor progress against project plans and revise/update as necessary throughout the lifetime of the study.
• Lead the combined study team ensuring exceptional cross-functional teamwork among team members including both internal and external stakeholders.
• Work directly with internal teams and external partners to create and proactively manage trial timelines, budgets, resources, vendors and strategy.
• Expertly maintain tracking and provide reports on clinical trial progress against timelines and budget. Monitor trial assumptions, schedule and costs to ensure all remain on track with the executed contract(s).
• Act as primary contact point with CROs, clinical sites and vendors for assigned trial(s).
• Works as a Subject Matter Expert (SME) within the team.
• Act as a mentor to one or more members of the Clinical Operations Team.
• Understand the trial delivery strategy, costing assumptions and resulting budget for assigned trial(s) in order to manage vendors.
• ‘Own’ study quality control and risk management activities to ensure trial deliverables are achieved by developing/agreeing key project performance indicators (KPIs) and Quality Tolerance Limits (QTLs) for study specific metrics, ensuring that the QTLs are not breached and KPIs are met.
• Track and forecast changes in SOW and associated budget including forecasting annual and 5 years planning /spend.
• Other duties as determined by business needs.

Qualifications, Skills and Experience:

• Must have a life science or nursing degree or a similar qualification.
• Must have significant previous trial management experience at trial management level on international clinical trials in pharmaceutical and/or CRO industries.
• Oncology clinical trial experience essential.
• Experience with Radiopharmaceutical clinical trial management highly desirable but not mandatory.
• Expert knowledge of ICH GCP, international regulatory requirements & guidelines for the conduct of clinical development programs is also a bonus.
• Excellent decision-making, facilitation, communication and organisational skills.
• Mastery in working collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Communicates effectively in understanding, interpreting, and explaining protocol requirements to others in a clear and concise manner.
• Must have prior monitoring experience as co-monitoring may be required.
• Strong coaching, facilitation, and organizational skills; team player.
• Experience and skilled with cross-functional and highly matrixed organizations.
• Demonstrated ability to handle multiple competing priorities, utilize resources effectively and adapt flexibly to changing priorities.
• Must have functional expertise to support departmental SOP development and implementation.
• Effective computer skills with good working knowledge of a range of computer programs.
• Team player.