About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
This position sits within Clinical Operations Excellence (COE) and serves as an expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. They will have a deep understanding of global site activation requirements and data flows across Astellas applications and reporting tools.
The Business Operations Manager will represent Clinical Operations both early and late on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across various therapeutic areas, trial designs, and global requirements to support the development of robust functional requirements for new or enhanced applications and reports.
This role will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions used for clinical systems. This role will work with business process and system owners to define user roles, permissions, and training requirements.
Key Activities for this role:
· Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
· Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements
· Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track
· Leading the preparation of study level essential document templates
· Aiding in the preparation of content for Regulatory submissions
Essential Knowledge & Experience:
· Solid knowledge of clinical trial conduct, including, multi-center, global trials.
· Strong knowledge of ICH/GCP guidelines and regulatory requirements.
· Requires proven project management skills and leadership ability
· experience in pharmaceutical related drug development
· Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
· Good command in English
Preferred Knowledge & Experience:
· Involved in working cross-functionally and collaborating with external providers
· Engaged in the development and implementation of process improvement initiatives
· Global Experience with site activation activities including submission requirements
Educations/Qualifications:
· BA/BS degree or equivalent.
Additional Information:
· This is a permanent, full-time position.
· Location: Addlestone, United Kingdom.
· This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
What We Offer:
· A challenging and diversified job in an international setting.
· Opportunity and support for continuous development.
· Inspiring work climate.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Job Types: Full-time, Permanent
Work Location: Hybrid remote in Addlestone KT15 2NX