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Senior Manager, Clinical Data Management

Employer
Bristol Myers Squibb Company
Location
Princeton, NJ, United States
Start date
Sep 18, 2020

View more

Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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.

The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management

This is an office-based position which may be located in New Jersey, Seattle, San Diego, Braine-l'Alleud (Belgium) or Boudry (Switzerland).

Position Responsibilities

Responsibilities will include, but are not limited to:

Project Management and Leadership
  • Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
  • Provides strong quality and project oversight over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Lead or support the Health Authority inspections and audits
  • Provides coaching and quality oversight of junior Data Management Leads


FSP/CRO/Vendor Oversight
  • May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)


Continuous improvement initiatives
  • Provides the relevant support and input to continuous improvement activities within clinical data management
  • Provides support for CAPA implementation as required


Degree Requirements

Bachelor's Degree required with an advanced degree preferred

Experience Requirements

At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

Key Competency Requirements
  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
  • Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
  • Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
  • Strong project management; Exhibits expertise in metrics analysisand reporting methodologies
  • Excellent oral and written communication skills
  • Communicate effectively with senior management and cross-functional teams
  • Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]


Travel Required

Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

NA

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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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