Global Trial Associate (Bristol mayer squibb)

Roles and Responsibilities

Roles and responsibilities:

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to the following:

Project Management

• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.

• Resolves routine problems and escalates important issues appropriately (with a sense of urgency).

• Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

• Understands study level tools and plans.

• Simple studies or studies in closure phase may be managed in alignment with OPL or GTL.

• Reviews vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changes

• Manages the development and/or collection of study level documentation and supports GTL in ensuring eTMF accuracy and completion for all studies.

• Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study SharePoint/study directory updates and the Global Vendor Site List etc.

• Provides operational input and participates in operational processes in support of startup maintenance and close out of studies.

• Assist the GTL in driving study execution.

• Learns, observes and performs core GTA tasks and escalates appropriately.

• Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.

• Raises possible issues for potential escalation to the appropriate colleagues.

• Follows instructions, determines level of understanding and seeks clarification when needed.

• Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.

• Supports study specific CSR appendices, as needed.

• Manages global vendor site lists and resolve issues related to global site lists.

• Manages study mail-groups/distributions and SharePoint/Study Directory updates.

• Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.

• Identifies issues and risks, develops mitigations, and escalates appropriately.

• Participates in filing activities and any associated audits as applicable.

• Lead assigned study closure/archival activities during study closure phase

Qualification and experience:

Specific Knowledge, Skills, Abilities:

Technical Competencies

• Basic knowledge of clinical research budgets including processing, reporting and tracking of vendor payments is a plus.

• Knowledge of ICH/GCP and regulatory guidelines/directives.

• Basic understanding of project management is desired.

Management Competencies

• Begin to network and foster relationships with key stakeholders across the study team.

• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

• Displays a willingness to challenge the status quo and take risks.

• Effective oral/written communication skills, ability to collaborate with key stakeholders and across the organization.

Education/Experience/ Licenses/Certifications:

• BA/BS or associate degrees in relevant discipline is strongly preferred

• 2-4 yrs of experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is preferred.

• Experience in Clinical Research or related work is a plus.

• Global experience is a plus.