DOCS Global

Oncology Global Study Leader (Early Phase)

Location
Gloucester, UK
Salary
Competitive
Posted
27 Apr 2021
Closes
27 May 2021
Ref
28706
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Basic requirements for the Global Study Leader (Oncology or BioPharma) role;
• For this role, we need you to have at least regional PM experience though global project management experience preferred as this is a lead global PM role
• You will need to understand the cultural difference between pharma and CRO
• Need to demonstrate an understanding of the global PM role
• Ideally at least 5 years clinical research experience and 3 years PM experience needed, along with the right-to-work in the UK.

Typical Accountabilities;
Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions. Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study documents in accordance with relevant SOPs.
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget. Ensure adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans as well as detailed and realistic study timelines.
• Accountable for ensuring that all systems utilized at a study-level (e.g. ACCORD, PharmaCM, etc.) are maintained.
• Accountable for leading the identification of overall study-level risk management activities. Ensure mitigation strategies are implemented effectively and that issue escalation pathways are clear to the entire study team.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators. Communicate key risks and proposed mitigations to applicable stakeholders.
• Maintain oversight over quality issue reporting in accordance with relevant SOPs and collaborate with all functions and/or external service providers as necessary to implement corrective and preventative actions.
• Oversee Trial Master File (TMF) completion from study start until archiving, in accordance with relevant SOPs.
• Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Clinical Trial Transparency, etc.).
• Accountable for study budget management (and re-forecasting where required) through the study lifecycle. Provide budget progress reports and highlight financial risks and mitigation plans.
• Maintain oversight of study inspection-readiness, in accordance with ICH-GCP, SOPs and relevant policies/guidelines. Act as the functional lead in the event of an audit or inspection.
• Oversee individual performance of study team members and ensure resource is utilized efficiently. Identify and communicate resource gaps for assigned studies. May mentor less experienced colleagues.
• Work on non-drug project work such as process improvements as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

Education, Qualifications, Skills and Experience

Essential;
• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research
• Minimum of 5 years progressive experience in early phase clinical research, with at least 3 years of clinical development project management experience (or equivalent)
• Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
• Demonstrated abilities in clinical study management processes and clinical/drug development
• Extensive and proven experience in driving operational delivery to timelines, cost and quality
• Strong strategic and critical thinking abilities
• Ability to manage complex situations. Proven complex problem solving and decision-making skills.
• Project management certification would be a plus
• Proven project management experience on a global level
• Experience in all phases of a clinical study lifecycle

What is offered
• Permanent contract of employment with DOCS seconded to the client;
• Full-time and home-based with willingness to attend the client office for training and ad-hoc meetings
• Competitive salary depending on level of skills and experience;
• Company benefits: 25 days' annual leave plus UK bank holidays, pension and healthcare.

Please send* your CV today to find out more at Elisabeth.Knighton@docsglobal.com

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