Clinical Trial Associate

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us
This position will manage administrative and business activities for site development related to the conduct of clinical trials with investigative sites from study start-up to study closure.

Position Responsibilities

• Demonstrates a good understanding of Expected Areas of Competence as stated within this position profile and consistently demonstrates strong skills and behaviours.
• Independently manages multiple site level deliverables during start-up, maintenance and closure both within BMS and external business partners and vendors.
• Utilizes technology effectively to support the clinical development process with the use of Clinical Trial Management System (VEEVA CTMS).
• Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure management and alignment on BMS business processes and execution of study timelines.
• Manages and makes decisions on the development and execution of study related binders and coordinates relevant study materials at study start-up.
• Responsible for site level source documentation within the Clinical Trial Master File to ensure accuracy and completeness of the TMF in preparation for audit and inspection.
• Collaborates with other internal roles in completing and reviewing CTP/Site activation documents for accuracy prior to drug shipment.
• Completes payment activities and tasks related to country regulatory authorities, ECs/IRBs, investigational sites and vendors including reimbursement activities such as related adverse event coverage
• Independently makes decisions and takes action within the scope of Clinical Trial Associate responsibilities, based upon professional background and knowledge of study, protocols, company procedures, ICH/GCP Guidelines and country, regional and local regulations.
• Completes assigned tasks/responsibilities on an increasingly independent and proactive scale.
• Resolves study-related issues independently using functional expertise and exercises good judgment in escalating issues as necessary.
• Proposes innovative solutions to optimize processes, etc.
• Determines actual regulatory or financial challenges and anticipates future ones, developing strategies to address and resolve potential risks and issues providing updates to Line Manager.
• Participates i n departmental/divisional/role special projects , cross-functional work groups , initiatives and task forces as opportunities arise.
• Makes proactive recommendations to management relative to department issues, policies, and procedures.
• Participates in issue identification at the team level and manages the resolution along with the line manager to enhance value of the position.
• Takes appropriate and informed business risks
• Enhances communication skills with both i nternal (Global level) and all relevant external parties with coaching from manager (if required)
• Collaborates as needed in sponsor and site audit/inspection-related preparation activities

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Role Requirements

• Degree: University degree in Nursing, Life Science, Healthcare, Administrative, Financial or Accounting related field.
• 1-3 years’ experience in Clinical Research or related work experience.
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
• Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…)
• Travel: expected t ravel to clinical trial sites in support of clinical research where required.

Position Responsibilities

• Demonstrates a good understanding of Expected Areas of Competence as stated within this position profile and consistently demonstrates strong skills and behaviours.
• Independently manages multiple site level deliverables during start-up, maintenance and closure both within BMS and external business partners and vendors.
• Utilizes technology effectively to support the clinical development process with the use of Clinical Trial Management System (VEEVA CTMS).
• Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure management and alignment on BMS business processes and execution of study timelines.
• Manages and makes decisions on the development and execution of study related binders and coordinates relevant study materials at study start-up.
• Responsible for site level source documentation within the Clinical Trial Master File to ensure accuracy and completeness of the TMF in preparation for audit and inspection.
• Collaborates with other internal roles in completing and reviewing CTP/Site activation documents for accuracy prior to drug shipment.
• Completes payment activities and tasks related to country regulatory authorities, ECs/IRBs, investigational sites and vendors including reimbursement activities such as related adverse event coverage
• Independently makes decisions and takes action within the scope of Clinical Trial Associate responsibilities, based upon professional background and knowledge of study, protocols, company procedures, ICH/GCP Guidelines and country, regional and local regulations.
• Completes assigned tasks/responsibilities on an increasingly independent and proactive scale.
• Resolves study-related issues independently using functional expertise and exercises good judgment in escalating issues as necessary.
• Proposes innovative solutions to optimize processes, etc.
• Determines actual regulatory or financial challenges and anticipates future ones, developing strategies to address and resolve potential risks and issues providing updates to Line Manager.
• Participates i n departmental/divisional/role special projects , cross-functional work groups , initiatives and task forces as opportunities arise.
• Makes proactive recommendations to management relative to department issues, policies, and procedures.
• Participates in issue identification at the team level and manages the resolution along with the line manager to enhance value of the position.
• Takes appropriate and informed business risks
• Enhances communication skills with both i nternal (Global level) and all relevant external parties with coaching from manager (if required)
• Collaborates as needed in sponsor and site audit/inspection-related preparation activitie

Role Requirements

• Degree: University degree in Nursing, Life Science, Healthcare, Administrative, Financial or Accounting related field.
• 1-3 years’ experience in Clinical Research or related work experience.
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
• Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…)
• Travel: expected t ravel to clinical trial sites in support of clinical research where required