Associate Director - Start Up and Operations Manager

GSK

Warszawa
Warszawa, Masovian
offer expired 4 months ago
contract of employment
full-time
team manager
hybrid work
remote recruitment

Your responsibilities

Accountable to lead the Local Clinical Operations Specialists to ensure timely Start Up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according Country regulations, GSK SOPs and GCP
Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation
Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance
Accountable through the Clinical Operations Specialist and through collaboration with key stakeholders (Legal, Data Privacy Office, Procurement, Regulatory) that all Clinical Trial contracts are well managed through the Fair Market Value approach as proposed study by study by GSK Central Teams as well as through the integration of GSK Global / Local legal contract prerequisites
Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams
Responsible for resource management and allocation to maintain business performance and a sustainable workload
Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model
Responsible for study archiving on the country level
Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the development of clinical research activities / investigator partnerships
Is the point of contact for the FSP CRO CTC Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice
Accountable for managing locally all clinical operational aspects related the Regulatory Vault approach
Responsible for overseeing/managing staff resource utilization across the department in collaboration with FSP Managers
Responsible for managing Third Party Vendors performance
Keeping track on GMASE/department and CRO metrics and making appropriate recommendation to the LT to ensure continued improvement

Our requirements

Any General Science Degree (i.e. life science, medicine, clinical research, pharmacy); other degrees or no degree can be considered if work experience in clinical research is substantial enough
A minimum of 5 years’ experience in clinical operations
2 years in line management experience
Profound operational knowledge of clinical research with experience in all stages of study lifecycle and understanding of R&D process
Good written and verbal communication skills in English
Strong computer skills: advanced/expert level of MS Office (PowerPoint, Excel, Word and Outlook)
Working knowledge of current clinical trial regulation
Given the nature of the job and accountabilities for local execution, project management skills are required to coordinate across all deliverables and manage local study teams to meet time, cost and quality requirements

Optional

Developing people and building a talent pipeline in line management environment
Stakeholder management skills required as the role includes interactions with senior stakeholders at a central and at a LOC level
Demonstrated management competencies in decision-making, accountability, study management, communication, problem solving, teamwork, negotiation, developing others and mentoring
Collaborative and open leadership style. Adapts management style to different situations independently and as appropriate
Ability to set baseline targets, track trends and implement mitigation plans
Acts as role model in line with GSK values and expectations

What we offer

Interesting job in one of the leading global healthcare companies
Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
Opportunity to work within GSK standards and documentation applied globally
Possibilities of development within the role and company’s structure
Contract of employment
Wide range of benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, company car)
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement)

Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs - min 40% of time in the office)
Friendly work environment and great atmosphere in our teams
Corporate culture based on our values: patient focus, integrity, respect and transparency
Personalized learning approach (mentoring, online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day

Benefits

private medical care
retirement pension plan
leisure zone
employee referral program

The Study Start Up Manager is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. This includes, but it’s not limited to the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPO Management for core/priority and auxiliary/other countries.

The role is the accountable person and single point of accountability for the study Start Up Metrics.

This position works directly with Clinical Operations Director, LDL Managers, SEL/LDL, Global SSU Managers, CRO FSP (Functional Service Provider) CRA/CTM/CTA Managers in setting priorities and expectations for Study Start-Up.

This position also manage Clinical Operations Specialist Team and other functions involved in study start up activities, depending on Countries.

GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get ahead together.

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