TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Global Clinical Trial Business Capability Lead, Trial Transp

Company: Adecco Group
Location: Princeton
Posted on: April 10, 2021

Job Description:

Global Clinical Trial Business Capability Lead, Trial Transparency & Disclosure Capabilities

  • Clinical Dev
  • R1526317
  • Full Time
  • 2021-01-12T00:00:00+0000 mail_outlineGet future jobs matching this search or Job Description At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.--In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Profile Description The Clinical Trial Business Capability Lead (BCL), Trial Transparency & Disclosure Capabilities role will provide overall leadership and governance of a GDO business capability end-to-end, encompassing process and technology strategy implementation. The BCL will be acting as the primary point of contact and advisor for the business capability stakeholders across Global Drug Development through proper stakeholder engagement and management.--Success in this role will require ensuring proper demand management, prioritization and evaluating process impact assessments of key change initiatives ensuring value is delivered through the business capability. The role is also accountable for executing the business capability governance and process strategy including the use of technologies and related systems in support of clinical trial research programs. The role also ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Trial Transparency & Disclosure capabilities, including technology systems such as Clinical Trial Registration & Results (CTRR) and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability. By adhering to local, regional, and national requirements for clinical trial disclosure, BMS is committed to publicly sharing information on the clinical trials we conduct, regardless of the outcome. We also believe in providing access to clinical trial information to researchers who seek to advance science in alignment with the PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing and support enhanced transparency and sharing of clinical trial data with researchers, clinical trial participants, regulators and patient advocates. BMS is committed to honor legitimate requests for our clinical trial data from qualified researchers by providing access that also protects patient privacy, respects the integrity of global regulatory systems and maintains incentives for those who invest in biomedical research. CTRR as well as other technology solutions are used to achieve these transparency and disclosure commitments. This role is responsible for the overall leadership of the Trial Transparency and Disclosure Capabilities. Key Responsibilities and Major Duties
    • Serves as the Business Capability Lead/Subject Matter Expert for the business capabilities, including system/technology, regulatory inspection/internal audit.
    • Leads development of an optimized capability for registration and result disclosure according to current global regulations.
    • Leads the implementation of a data sharing capability to enhance the experience of researchers seeking clinical trial data for secondary research.
    • Owns the governance strategy, roadmap, execution, and monitoring of the business capability
    • Effectively managing, partnering and engaging with internal and external key stakeholders as per governance strategy to ensure business needs and regulatory requirements are met, prioritized and communicated.
    • Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
    • Ensures proper documentation and oversight of all business processes, standard procedures and work instructions related to business capability ensuring compliance with regulatory requirements
    • Develop and implement operational support model, communication plan and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective.
    • Partners with IT and platform providers (SaaS) to set and drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
    • Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
    • Works broadly across Global Development Operations, Global Clinical Compliance & Continuous Improvement, Medical, Commercial, IT, Public Affairs and Legal to leverage digital expertise and capabilities across the enterprise.
    • Accountable for system/technology performance, analytics/metrics, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.
    • Oversees system/technology work streams and outcomes.
    • Contributes to internal/external continuous improvement initiatives.
    • Monitors new technologies and external trends to ensure BMS is leveraging the best of what is available
    • Monitors and oversees business capability operational health and metrics
    • Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
    • Participate in audits and inspections for the business capability to ensure data requests by auditors and agencies are met Requirements: Bachelor's degree required with an advanced degree preferred. Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities. Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.
      • Experience in clinical trial, data, or technology management
      • Knowledge of GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)
      • Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices
      • Experience with Clinical Trial Disclosure software solution(s)
      • Understanding of the patient experience and perspective in clinical trials
      • Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
      • Ability to analyze and interpret complex issues and propose innovative solutions
      • Experience with leading teams and driving innovation
      • Strong project management and planning skills
      • Effective oral and written communication skills to influence, inform, or guide others
      • Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
      • Experience working in a matrix environment. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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 with the resources to pursue their goals, both at work and in their personal lives.

Keywords: Adecco Group, Trenton , Global Clinical Trial Business Capability Lead, Trial Transp, Healthcare , Princeton, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

Companion Caregiver - Urgently Hiring
Description: We are looking for caregivers, of all experience levels, to become a part of our caregiver network Dependable, compassionate, and upbeat caregivers who can provide companion care, personal care, and/ (more...)
Company: CareInHomes
Location: East Moriches
Posted on: 04/15/2021

Skilled Nursing Travel RN - Job Id: JO03023973
Description: Next Travel Nursing is seeking a qualified
Company: Next Travel Nursing
Location: Smithtown
Posted on: 04/15/2021

$16.00 CNA-Immediate Hire (Southampton)
Company: Five Star Staffing
Location: Smithtown
Posted on: 04/15/2021

Companion Caregiver - Urgently Hiring
Description: No Certification No Problem We are hiring caregivers of all skill levels to provide compassionate In Home Care to some
Company: CareInHomes
Location: Coram
Posted on: 04/15/2021

Physical Therapist - Travel Contract
Description: br Provide expert therapy to patients with injuries and/or illnesses to help them improve movement, manage pain, and/or prevent the loss of mobility at state-of-the-art facilities across the U.S. Partner (more...)
Company: Jackson Therapy Partners
Location: Medford
Posted on: 04/15/2021

RN - Home Health
Description: Host Healthcare has a great travel nurse opportunity. A prestigious facility is looking to hire a travel nurse. This is an opportunity to earn top pay while
Company: Host Healthcare
Location: Hauppauge
Posted on: 04/15/2021

NP / Registered Nurse / New York / Any / Psych Nurse Practitioner or PMHNP (Part time) Job
Description: PSYCH NP NEEDED WITH TOP HEALTH SYSTEM IN GREATER NYC AREA ul li Full time position li Patient-centered
Company: K.A. Recruiting, Inc.
Location: Centereach
Posted on: 04/15/2021

NP / Registered Nurse / New York / Any / Psychiatric Nurse Practitioner OR PMHNP Job
Company: KA Recruiting, Inc.
Location: Holbrook
Posted on: 04/15/2021

Description: Our Story: Fusion isn't just a job it's a lifestyle. Our actions are rooted in ensuring everyone we touch has a better life. Here, we don't just work hard and play hard every day we do it with a purpose. (more...)
Company: Fusion Medical Staffing
Location: Smithtown
Posted on: 04/15/2021

Caregiver - Flexible Scheduling Available
Description: No need to job search any further, we have the caregiver position that you've been looking for Apply now and you can start within the week Full-time or part-time, morning, afternoon, or evening shifts (more...)
Company: CareInHomes
Location: East Moriches
Posted on: 04/15/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds