Study Manager CAR T within late-stage Medical Affairs

Jobbeschreibung

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

With a number of compounds now in late-stage development, we are seeking a Study Manager to oversee Non-Interventional studies for our Medical Affairs Operations team.

In this role, you will provide operational leadership of Non-Interventional (NIS) and/or Interventional Studies within their remit. The successful candidate will also be accountable for study execution on time, within budget, and to high quality standards, in compliance with Celgene's regulatory strategy, applicable regulations and procedures.

The Study Manager is the primary operational contact for the study/studies between our organisation and the Contract Research Organizations (CROs), and any other vendors. You will lead the cross-functional Study Team, upholding the study progress and quality of deliverables via collaborative partnerships, exercising the appropriate level of oversight as required for specific activities and/or situations with impact on performance.

You will also be responsible for providing accurate and succinct study status updates at regular intervals, and on request, to stakeholders both within and outside of our company.

You are someone who is already working "in industry" (for another pharma or biotech organisation) and who, ideally, has experience managing co-operative groups (blend of physicians and academics).

Please note: This role can be upgraded to Senior Manager, if you can demonstrate that you have the exceptional experience and knowledge.

Responsibilities

Project Management

• Drive study execution in line with pre-agreed objectives
• Oversee Study Team performance, quality of deliverables, and adherence to established processes and plans
• Develop, manage, and maintain study deliverables [such as: timelines and study plans] through collaboration with internal and external stakeholders, using data and strong inter-personal influencing skills, to agree robust data driven decisions.
• Proactively identify potential risks and develop and implement a risk and issues mitigation plan, balancing such risks and actions against study deliverables and costs.
• Maintain and update on study information, as appropriate, in project management tools, including CTMS
• Inform operational program lead(s) and other leadership (as appropriate) on overall study plans, forecasting, and of any potential risks and plans for issues mitigation

Study Planning and Conduct

• Facilitate country and site feasibility and selection processes
• Provide operational and strategic input into study documents such as study synopsis, protocol, ICFs, CRFs, CRF Completion Guidelines, Study Execution Plans, Comprehensive Data Review Plan (CDRP), Clinical Study Report (CSR), and publications.
• Oversee investigational product [IP]supply forecasting and management, and study-level IP reconciliation for Interventional Studies
• Oversee required country regulatory and country and/or site Ethics Committee submissions, notifications and approvals. This includes review of site regulatory packages and obtaining appropriate country and/or site insurances.
• Lead the development of the subject recruitment and retention strategy and related initiatives
• Participate in clinical service provider (vendor) selection, specification development, and oversight
• Oversee the TMF set-up, ongoing quality review, and final reconciliation of study documents to ensure audit/inspection readiness at all times
• Lead the development and coordination of study training for the Study Team, investigational sites, and vendors
• Provide study status updates for regulatory reporting such as NDA and PSURs/DSURs, as appropriate
• If overseeing an Affiliate NIS: Provide guidance to Affiliate operations personnel regarding processes for approval, start-up and management of local Medical Affairs Celgene Sponsored Studies. This includes preparations for study concept submission to the Internal Review Committee (IRC), study tracking and reporting, and filing of essential documents, to ensure studies meet regulatory and quality requirements.

Financial Planning and Management

• Proactively leads the development, management, and reconciliation of overall study budget(s), and forecasting in partnership with Finance
• Proactively leads the development and management of the vendors' scope of work (SOW) during the initial contracting process and for changes, thereafter, resulting in contract amendments/change orders
• Reviews and approves vendor invoices in a timely manner

Relationship Management

Build and maintain collaborative relationships with:

• Internal partners/stakeholders in the following functions among others: Biostatistics, Data Operations, Global Drug Safety and Risk Management (GDSRM), Portfolio Sourcing and Relationship Management (PSRM), and the Affiliates
• External partners including CROs, Academic Research Organizations (AROs), and other clinical service providers

Background

Education & Knowledge - essential prior experience:

• Graduate qualification preferably in medical or science area or equivalent work experience.
• Minimum 4 years business experience required preferably in the biotech or pharmaceutical industry.

Education & Knowledge - preferable prior experience:

• Minimum 6 years business experience required preferably in the biotech or pharmaceutical industry, including minimum 2 years in team or study management.

Functional Scientific & Technical Skills - essential prior experience:

• Good study management expertise
• Good knowledge of GCP/ICH and local guidelines, regulations and directives applying to interventional and non-interventional studies
• Excellent oral and written skills
• Advanced computer technical skills
• Develops/manages clinical trial budgets with some guidance
• Good cross functional awareness

Functional Scientific & Technical Skills - preferable prior experience

• Strong study management expertise
• Advanced project management skills with little assistance over time
• Advanced knowledge of GCP/ICH and local guidelines, regulations and directives applying to interventional and non-interventional studies
• Develops/manages clinical trial budgets independently
• Advanced cross functional awareness

Organizational Impact - essential prior experience:

• Executes/delivers on corporate objectives
• High organizational impact
• High impact on study team
• High impact on function
• Leads global cross functional teams / complex projects
• Acts as mentor within function; leads team

Traits of an Independent worker - essential prior experience:

• Requires minimal oversight
• Leads global clinical trials
• Manages complex/ multiple projects
• Effectively multi-tasks and sets priorities with minimal guidance
• Oversees service providers with minimal supervision

Creativity / Problem-Solving:

• Proactively identifies problems and implements resolutions
• Anticipates issues / challenges and creates contingency plans
• Provides strategic input to study team
• Understands interdependencies and links possible solutions
• Escalates issues with proposed solutions to appropriate people
• Reacts with a sense of urgency and responds appropriately
• Leads development of Medical Affairs best practices

Teamwork / Influence:

• Leads and drives Study Team
• Holds self and others accountable for accomplishing goals
• Strong negotiating and influencing skills
• Coaches and mentors team members
• Actively manages team behaviors and positively influences
• Promotes energy and commitment among team members
• Mediates internal team disputes
• Incorporates global considerations
• Builds effective cross functional relationships
• Identifies, participates and / or leads initiatives with cross-functional team / global teams
• Recognizes and rewards team accomplishments

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Extra Informationen

Status

Inaktiv

Ausbildungsniveau

Andere

Standort

Bundesweit

Arbeitsstunden pro Woche

8 - 40

Jobart

Nebenjob/Wochenendjob

Tätigkeitsbereich

Marketing / Kommunikation / PR / Werbung

Führerschein erforderlich?

Nein

Auto erforderlich?

Nein

Motivationsschreiben erforderlich?

Nein

Sprachkenntnisse

Deutsch