Expanded Access Manager Oncology
Site Name: USA - Pennsylvania - Upper Providence, Zug House, USA - Massachusetts - Waltham
Posted Date: Jan 2 2020
Are you interested in managing all processes from the initial study request through the study close out? If so, the Clinical Research Manager - Global Medical Affairs Research position might be for you!
The Clinical Research Manager for Access Programs is responsible for managing the strategic and operational components of global medical affairs activities, with a focus on access programs (Compassionate Use and Expanded Access).
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead access program operations from planning through close out, including support for internal review and approval, budget assessment, safety reporting, vendor management, IP stock and delivery, as well as the tracking of documents, agreements, contracts and key correspondence. This role interacts with many internal and external cross functional teams.
- Work closely with global and local medical affairs teams and cross functional stakeholders to deliver patient access for designated GSK oncology products.
- Provide day to day management of compassionate use and expanded access programs:
- Provide program coordination support including status tracking, IP management, safety reporting, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice
- Management of vendors to support access execution
- Lead and co-ordinate the development and management of expanded access protocol, regulatory document collection, timelines and metrics; ensures timely and quality deliverables
- Partner with CMC and other functional areas to plan, forecast and management clinical supply (IP)
- Develop project materials and tools to support effective operationalization and communication
- Develop strategy, materials and tools to support streamlined and effective transition from Investigational Medicinal Product (IMP) to locally approved commercial presentations
- Proactively identify potential delivery issues and risks and ensures corrective actions in case of deviation, communicates to stakeholders
- Track milestones and timelines
- Provide regular status and issues reports to Cross Functional Teams and Senior Management
- Continually support/help develop department initiatives and process improvements
- Proactively incorporates learnings and recommendations from one EAP to another; identifies needs for process standardization and regulatory compliance direction
- Bachelors Degree in a scientific or clinical area and 5 years experience in pharmaceutical or CRO industry or Masters Degree in scientific or clinical area with 2 years experience in pharmaceutical or CRO industry
- Direct experience with clinical research in a study manager or CRA role, or other applicable experience
- Thorough knowledge of FDA, ICH, GCP, and OIG guidelines.
- Previous experience managing compassionate use or early access programs
- Background in oncology
- Prior clinical project management or expanded access program experience
- Proven success working in a team setting and contributing to team success
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
- Strong problem solving skills
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
- Comfortable with ambiguity and has the ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
- Self-motivated, assertive, and self-confident, with the ability to act with urgency and passion
- Flexible, resourceful, creative, enthusiastic, and results-oriented
- Enjoys working in a fast-paced environment
- Understanding of cross-functional stakeholder key responsibilities (Supply Chain, Regulatory, PV, Legal, Medical Writing, LOC Medical Leads, etc.)
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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