Bristol Myers Squibb SENIOR CTA CZ in PRAHA, Czech Republic
Senior Clinical Trial Associate CZ
Demonstrates a good understanding of Expected Areas of Competence as stated within this position profile and consistently demonstrates strong skills and behaviors
Independently manages multiple site level deliverables during start-up, maintenance and closure both within BMS and external business partners and vendors, when required.
Validates, submits and follows-up the initial clinical trial application, amendments, ongoing reporting and end of trial notifications to country regulatory authorities, ethics committees / institutional review boards, and investigational sites for timely approval
Collaborates with other internal roles in country feasibility and site selection.
Collaborates directly with the Company internal study teams, external site staff, country ethics committees/IRB to ensure management and alignment on Company 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.
Trains and develops clinical site staff in the execution of regulatory documentation.
Drives the collection and review of site regulatory documentation directly from sites with a focus on embedding quality within the TMF in accordance with SOPs, GCP and regulatory guidelines.
Responsible for site level source documentation within the Clinical Trial Master File to ensure accuracy and completeness of the trial master file 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 Complete payment activities including reimbursement activities such as related adverse event coverage
Is independent in budgets revisions and preparations for sites.
Negotiates clinical trial agreements independently assessing the requirements and need to support decisions by legal council.
Takes ownership for preparations, revisions and accuracy of the critical financial documents (e.g. contract templates) and the processes related to all steps of clinical trial contracting and site payments
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.
Knowledge of the integrated clinical development process through exposure to support of clinical projects. To be enhanced by attendance and occasional presentation at regular team meetings, internal/external training courses, workshop and seminars, where appropriate.
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.
Opportunity to further develop skills in various technical applications.
Proposes innovative solutions to optimize processes, etc.
Opportunity to enhance time management, prioritization and project management skills by supporting multiple by supporting multiple GCO clients with competing timeline constraints
Opportunity to enhance teamwork skills by supporting information sharing & collaboration within the cross-functional environment.
Instinctively collaborates across organizational, functional and geographic boundaries to achieve departmental and company goals.
To build and expand on expected areas of competence as stated within this position profile.
Ability to exhibit flexibility and being receptive to new systems and processes; and willing to enhance current skills to maximize proficiency.
Participates in 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.
Takes appropriate and informed business risks
Enhances communication skills with both internal (Global level) and all relevant external parties with coaching from manager (if required)
Demonstrates the ability to impact and influence others within a team to take action and contributes towards the establishment of best practices through coaching and feedback
Provides role-related assistance, coaching and mentoring to colleagues, as requested by peers or manager.
Manages the team’s workload together with the line manager, to assure the accomplishment of metrics and goals and provides supervision to other staff members, as needed.
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…) to coaching other team members.
Effectively coordinates with other departments: GOO, GCO, GRS, GMA, global, CROs, CSO, GDDM etc, as required.
Works well in a team environment with little or no supervision by demonstrating the ability to think in a logical decisive manner and demonstrates a "can do" approach. Utilizes effective problem-solving approaches and independently follow-up and resolves outstanding issues, within deadlines.
Interacts effectively with a wide range of individuals, both external and internal customers, collaborates effectively with internal groups and individuals to achieve key deliverables and responds proactively to site supply needs.
Exhibits professionalism and strong business ethics by maintaining confidentiality where appropriate, exhibiting candor and honesty with both internal and external key stakeholders , and respecting Company policies and privileges.
Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external customers (e.g. safety up-dates, amendments, administrative letters, newsletters, assignment changes, etc.).
Demonstrates a general understanding of the clinical research process and utilize organizational skills to assists with the coordination, planning, implementation and administration of projects during all phases of the protocol execution in accordance with established timelines and standard operating procedures.
Provides on-going training and mentoring to team members through a mentoring process using informal and/or formal presentations (provided by level of experience or Senior CTA). Contribute to study team and HUB performance.
Consistently demonstrates initiative and drives performance by contributing to productivity enhancements and improvement by participating in CTA meeting.
Ability to participate as an active member of cross-functional teams, task forces, or local and global initiatives, presentations, and task forces. Seeks to identify and implement best practices.
Clinical Trial Management System (CTMS – ECLIPSE)
Electronic Trial Master File System (eTMF)
Document Exchange Portal (MyTrials)
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.