Bristol-Myers Squibb Company

Clinical Trial Lead

Location
Princeton, NJ, United States
Posted
Jun 06, 2019
Ref
R1516110
Required Education
Doctorate/PHD/MD
Position Type
Full time
** The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **

Job Description

Work with the Program Lead and team members to translate the FDT strategy into trial options and protocols

Clinical monitoring of one or more studies

Medical Data Review (and data cleaning support as appropriate) of ongoing studies working with Clinical Operations and Data Management.

Addresses relevant clinical queries from study sites with documentation in eTMF

Identify and builds relationships with investigators

Contributes to DSURs and PSURs

Supports generation and coordination of clinical documents and deliverables in support of regulatory filings

Work consistently in a matrix environment

MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge

The position is based in the Princeton, NJ area

Job Requirements

Responsible for the study timelines in a cross-functional matrix protocol team

Responsible for the clinical development activities from site(s) initiation to study discontinuation

Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements

In collaboration with GRS and GPV&E, designs and implements safety monitoring plans

Interprets clinical data and makes appropriate decisions and recommendations

Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions

Work with the Program Lead, team members and governance bodies to translate the FDT strategy into trial options, protocols and action plans

Work with the Program leads to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview

Addresses relevant clinical queries from study sites; and authors responses to study related HA and IRB questions

Identify and builds relationships with study investigators

Is seen and acts as the study expert by the site personnel

Ability to work and communicate efficiently with internal partners in the US for positions located outside the US

Identify and builds relationships with principal investigators

Identify Thought Leaders and use them for inputs in clinical strategy and protocol design

Maintain a strong medical/scientific reputation within the disease area

Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies

Share specific clinical strategies with other clinical teams

Study-specific clinical design and execution

Manage communication with key stakeholders (senior)

Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry - e.g. monitoring)

Management of one or more uncomplicated studies and preparation of regulatory documents

New entrance to pharma: out of fellowship/ new to industry

Limited clinical research experience (substantial academic research experience could potentially substitute)

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

Relevant clinical research experience (relevant academic research experience could potentially substitute)

Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock

Has a history of handling multiple, complex, studies in parallel

Has a history of prior meaningful participation in regulatory submissions

Has a history of strong interaction with thought leaders

Proven team leadership capability

Performs as an individual contributor

Identifies when an issue is present and begins to address