Associate Study Start-Up Manager, Brazil - IQVIA

Descrição

Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where your skills can take you. Our team is looking for an experienced professional with site activation, amendment, and lead experience. This person should have hands-on experience activating sites in the LATAM region as well as North America. In addition, the applicant should demonstrate at least 2 years of leadership experience. English proficiency both in writing and verbal communications is required. Please submit a resume in English.


BASIC FUNCTIONS:
The Associate SSU Manager is responsible for providing management of start-up activities for designated tasks within defined projects.

This includes but not limited to acting in the following positions:

Amendment lead

An ASSUM will be assigned to the study when the study is over 80% activated in all countries (described in SSU Plan) The ASSUM will remain on the study until the end of Trial and will be responsible for all Maintenance activities

Junior SSUM

The ASSUM can be assigned onto projects in the start up phase to support the SSUM with a defined list of responsibilities or to support a 1-2 country study outside of North America.

May also be assigned to support North America only studies, as applicable.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Amendment Lead When allocated as an amendment lead the ASSUM will be responsible for, at a minimum, the following activities:

Oversight of the planning, submissions and approval stage of protocol amendments during the maintenance phase of the study
Updating the Amendment Addendum in the Study Start-Up (SSU) Plan or create the Amendment Plan for those studies without a SSU plan
Oversight for the Ethics Submission approval processes (including, but not limited to timeline management, ensuring core documents are received timely, Site Contract Amendments etc, if required according to the SSU /amendment Plan

Collaboration with relevant stakeholders e.g PM, Regulatory, Site Contracts, CTM and LSSUS throughout the process to ensure all timelines are met and all work is completed in accordance with relevant SOPs/ WPs.

Maintain and manage SSU data tracking entries in relevant databases. Review for completeness and accuracy.
Preparing and providing reports to study management as appropriate

Junior SSUM When assigned in the position of a Junior SSUM the ASSUM can assume responsibility for the following activities, the exact scope of role will be determined at the start of each allocation in collaboration with the Line Manager and/or SSUM, as applicable.

The ASSUM may support projects independently or as support to a SSUM.

Lead SSU team or service line in all activities during start-up phase. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs.
Develops, with the input of regulatory and contracts, a study specific SSU plan.
Communicates overall site activation status to internal teams and sponsor.
Directs the process for the selection of study sites and investigators. Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.
Where applicable, provide work instructions to team members in preparation of regulatory submissions.
Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.

Facilitates communication with the clinical team (e.g., SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring to ensure site activation timelines are met.

Directs the development of study start up review plans.

Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP).

Prepare and QC study start-up data reporting to internal teams and/or Sponsors. This could include InfoStart reports, SAPT reporting, reporting on country / site status.
Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges

Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.

Reviewing and identifying project study trends and proactively responding to client and respective team members. Provide feedback to management on site performance metrics.
Provide oversight of LSSUS activities for key deliverables within the project e.g., EC submissions and GLP collection.

Implement and manage a risk-based approach to all activities, identifying potential obstacles to the successful completion of deliverables and developing innovative solutions to challenges.

Ensure project level compliance with study specific training requirements outlined in the study training matrix.
Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work
Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
May act as back-up on currently allocated for SSUM during time out of office
Provide directional insight for Change Orders and Out of Scope work.
Responsible for management of project timelines ensuring activities are completed by the timelines agreed.

May assist the study management team with continuous planning of work completed versus ongoing requirements which will feed into the overall budget management of the study.

For both roles the ASSUM is expected to:

Maintain compliance with IQVIA Biotech SOPs, CAPA completion and timesheet maintenance in accordance with IQVIA Biotech standards.
Performs other duties as required and agreed with Line Manager.

KNOWLEDGE,


SKILLS AND ABILITIES:
Strong knowledge of clinical research processes related to study start-up.
Excellent organizational and interpersonal skills
Ability to work independently, prioritize and work within a matrix team environment required.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Demonstrated knowledge of quality assurance related to study start-up.
Demonstrated ability to form strong working relationships across functional boundaries.
Demonstrated ability to motivate, lead a study start up team.
Excellent written and verbal communication skills.
Ability to handle multiple priorities within multiple, complex clinical trials
Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
Extensive working experience with Microsoft Word, Excel, and Power Point
Strong communication skills (verbal and written) to express complex ideas
Ability to set baseline targets, track trends and implement mitigation plans

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very limited physical effort required to perform normal job duties.
Travel may be required, including international travel
Must be able to secure a credit card cosigned by IQVIA Biotech


MINIMUM RECRUITMENT STANDARDS:
Bachelor's degree (or equivalent), preferably in science or related field and - 7 years relevant experience, including at least 2 years of regulatory & study-start up experience
At least 2 years of demonstrated leadership experience
Equivalent combination of education, training, and experience

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