Senior Global Trial Specialist

1+ years

Not Disclosed

Hyderabad

10 July 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Working with Us at Bristol Myers Squibb

Overview:

Challenging. Meaningful. Life-changing. At Bristol Myers Squibb, we redefine what a job can be. Unique and impactful work happens daily in every department. From optimizing production lines to breakthroughs in cell therapy, our work transforms patient lives and careers. Grow and thrive through unparalleled opportunities with high-achieving, diverse teams.

Balance and Flexibility:

We recognize the importance of work-life balance and flexibility. Our competitive benefits, services, and programs provide resources for employees to achieve their goals at work and in their personal lives.

Job Title:

Phase IV Senior Global Trial Specialist

Division:

Research and Development

Functional Area Description:

Collaborate with cross-functional global teams to execute assigned operational aspects of complex global clinical research studies from protocol development to final clinical study report, crossing all therapeutic areas and research phases.

Position Summary:

Operational Execution:
- Ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
Team Participation:
- Participate in cross-functional study teams and/or performance and quality oversight of CRO teams and vendors.
- Work on routine to complex projects/trials at varying stages, supporting multiple complex trials as needed.
Task Management:
- Achieve corporate and study team goals, complete assigned tasks, participate in service provider oversight, and set priorities with guidance.
- Manage multiple assignments and operational processes with moderate to minimal supervision.
Functional Impact:
- Have a high functional impact on the study team and organization.

Position Responsibilities:

Project Management:
- Provide operational input and facilitate processes as a SME in support of startup, maintenance, and closeout of studies.
- Use performance metrics and quality indicators to assist the Global Trial Manager in driving study execution.
- Identify potential risks and develop/implement actions to avoid or mitigate.
- Resolve routine problems and escalate important issues appropriately.
- Actively contribute as a key functional member on cross-functional teams.
Study/Project Planning, Conduct, and Management:
- Provide input to study level tools and plans with moderate to minimal supervision.
- Perform core GTS tasks independently and escalate/delegate appropriately.
- Lead components of study meetings and contribute to oversight of country regulatory and site IRB/IEC approvals.
- Work on various trials at varying stages/complexity with minimal guidance.
- Understand strategy and decision-making at the program level and their impact on studies.
- Contribute to process development and improvement initiatives.
- Assess situations and identify paths forward with appropriate resources.
- Manage vendors and site payment processing and tracking.
- Maintain study budget tracking tools and reconcile invoices with overall contract/budget and finance reports.

Degree Requirements:

BA/BS or equivalent degree in relevant discipline.

Experience Requirements:

Minimum 1 year experience in Clinical Research or related work experience.
Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.
Global experience required.

Key Competency Requirements:

Technical Competencies:
- Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process.
- Knowledge of clinical research budgets, including processing and tracking of site and vendor payments.
- Working knowledge of project management preferred.
Management Competencies:
- Network and foster relationships with key stakeholders across the study team.
- Respond flexibly to changing business demands and proactively look for ways to contribute.
- Act as a role model in supporting change within the organization.
- Mentor and coach team members and participate or lead departmental initiatives.
- Build relationships to achieve influence with others.
- Develop and maintain collaborative relationships with internal and external stakeholders.
- Display willingness to challenge the status quo and take risks.
- Communicate effectively across the matrix organization and to key stakeholders.

Application Encouragement:

If you find a role intriguing but it doesn’t perfectly align with your resume, we encourage you to apply. You might be one step away from transformative work and a life-changing career.

Uniquely Interesting Work, Life-changing Careers:

With the vision "Transforming patients’ lives through science™," each BMS employee plays a vital role in extraordinary work. Our inclusive culture and diverse clinical trials promote passion, innovation, urgency, accountability, inclusion, and integrity, bringing out the highest potential in each of us.

On-site Protocol:

Occupancy Structure:
- Site-essential roles: 100% onsite presence.
- Site-by-design roles: Eligible for a hybrid model with at least 50% onsite presence.
- Field-based and remote-by-design roles: Require physical travel for meetings and customer interactions as essential functions.

Accessibility and Inclusion:

BMS ensures people with disabilities excel through a transparent recruitment process, reasonable accommodations, and ongoing support. Applicants can request accommodations during the recruitment process by contacting adastaffingsupport@bms.com. Visit BMS Equal Employment Opportunity for our complete statement.

Well-being and Vaccination Policy:

BMS prioritizes the well-being of our staff, customers, patients, and communities. We recommend all employees be fully vaccinated for Covid-19 and stay up to date with boosters.

Equal Opportunity Employer:

BMS is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or any other protected class. We consider qualified applicants with arrest and conviction records, per applicable laws.