clinical research trial manager resume example with 5+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
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Professional Summary
Highly skilled Medical Graduate with exceptional and strong leadership abilities; experienced in Pharmaceutical Sales and Clinical Research. SPONSOR’s and CRO’s direct communication; Clinical Trials experience (Phase II, III & IV); Budgeting, Action Oriented; Boss Relationships; Integrity and Trust; Interpersonal Savvy; Learning on the Fly; Listening; Organizing; Planning; Priority Setting; Problem Solving; Self - Knowledge; Standing Alone; Technical Learning; Time Management.
Skills
Fluent in English and Spanish
Clinical Research Management
Clinical Trials Management
Contract and Budgeting
Clinical Operation Management
Project Management
Work History
Operations Director, 12/2022 - Current Ascension Health – , , Houston, TX
Provide leadership, oversight, strategic and operational support to the Clinical Operations team, aligned therapeutically and by program
Guide the operational strategy and tactics to develop, execute and deliver clinical studies/programs with a focus on speed, cost, and quality
Provide direct management of Clinical Operations staff, including hiring, resource planning, performance management, and regular coaching
Manage alliances with strategic partners, including CROs and other vendors, to ensure operational plans, timelines, and budgets are aligned with corporate objectives and standards, as well as program goals
Assist with operational leadership and expertise in the development of Clinical Development Plans by providing strategic input into long-range planning activities within a program (e.g., budget, timeline, feasibility)
Advise and assist cross-functional colleagues in decision-making by providing the requisite information to drive informed business decisions
Oversee interdisciplinary activities by coordinating and collaborating with the Development Sub-Team (DST) and/or with clinical study teams to set goals and timelines, formulate strategies for execution, and escalate issues that may jeopardize timelines and deliverables
Drive quality-by-design efforts to proactively identify and manage risks to trial quality and ensure inspection readiness at all times
Oversee all aspects of study-level execution by the CTMs and CTAs, including but not limited to supervising site start-up and patient enrollment, clinical monitoring, compliance, and data flow metrics from clinical sites, CROs, and central labs
Participate in long-range financial planning by working with Clinical Operations staff and Finance to develop budgets, projections, and accruals and track financial status against program-level budget
Maintain knowledge of clinical principles and theories of drug development and study design in relevant therapeutic areas
Provide guidance and share learning within and across teams
Guide long-range career development for direct staff and mentees
Lead and/or participate in process development and process improvement initiatives
Perform administrative functions and additional duties as appropriate
Conducted audits of internal documents to validate transactions and provided financial guidance for resource allocation, inventory control and budgeting.
Recruited and hired top talent by selecting qualified individuals to maximize profitability.
Determined and initiated strategic business for quality control purposes, to boost delivery times and achieve cost-effectiveness.
Collaborated with executives to develop and execute strategic business plans.
Clinical Research Operations Manager, 02/2019 - 11/2022 Ohio Health – , , Houston, TX
Manage and execute one or more assigned clinical studies according to the objectives established by the project team and corporate goals. Responsible and accountable for all clinical operations activities related to the execution of the assigned clinical studies within the expected timelines, including:
Critical document development and review: Provide clinical operations input into clinical study protocol and informed consent form. Create clinical operations and clinical study document templates for utilization by the study team and study sites. Direct the development of eCRFs and other data management documents in collaboration with the Sponsor. Facilitate/direct the development of other study/project plans as required.
Study management: Manage all aspects of clinical study execution. Lead the study execution team meetings. Work with cross-functional counterparts to ensure that operational activities are executed/delivered according to the expected timelines and budget. Identify, establish, and ensure that study operational activities track to key study milestones agreed with the project team.
Timeline and budget management: Manage study timelines and budgets. Provide monthly budget forecasts and accruals to Finance. Review vendor invoices for accuracy and to ensure adherence to budget. Approve vendor invoices. Track and initiate investigator grant payments. Assist/support the development of clinical study budgets as required.
Vendor management: Enable timely study setup, site activation, patient recruitment, data entry and query resolution, and issue resolution. Track and manage out of scope activities.
Oversight of site selection and management: Develop site training materials and manuals. Ensure selection of qualified investigators and sites. Facilitate review and negotiation of clinical site agreements. Negotiate site study budgets. Ensure execution of site contracts in line with planned timelines. Proactively identify and remediate study issues.
Site management: Function as the primary study contact for clinical sites for studies or study activities managed internally (eg., site startup). Enable timely completion of milestones (eg., site activation, data cleaning, etc.) to support corporate objectives.
Routine study tracking: Track key study activities (eg., study startup, site activation, patient recruitment, patient status, data collection, data review, etc.) and maintain study metrics for routine reporting to the internal project team and management. Develop study-specific tools to ensure timeliness, standardization and control of quality data.
Routine study communication: Provide relevant clinical study operations updates to the internal project team and management, including any variances to the timeline or budget. Proactively identify solutions for issues that arise in study execution.
Trial master file oversight: Establish and maintain TMFs in line with departmental SOP.
Contribute to departmental organization, including review/input into departmental SOPs, harmonization of processes across studies, and mentorship of junior team members.
Clinical Research Associate, 05/2018 - 01/2019 HD Research – , , Houston, TX
Oversee clinical trial activities at investigational sites, which require travel to investigational sites and collaborating with sites and sponsors remotely.
Conduct visits and write accurate visit reports in accordance with SOPs, local law and applicable standards, including pre-study, site initiation, routine monitoring, and close-out visits.
Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
Thoroughly review informed consent documents to ensure consent was obtained and documented appropriately.
Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with source, known as source data/document verification (SDV).
Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data review (both internally and with sponsor), identifying and communicating trends or erroneous data.
Identify site personnel training gaps and re-train as necessary.
Work with sites toward resolution of action items between visits.
Determine and execute corrective and preventative action plans (CAPAs) with sites as needed, with support.
Lead Clinical Research Coordinator, 01/2017 - 04/2018 Company Name – , , Bellaire, TX
Reviews and develops familiarity with protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Coordinate, organize and maintain all documentation required by sponsor or CRO (source documentation, case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs.
Participate in conduct of audits by study sponsors, CROs, FDA, and other entities as required.
Process and ship blood, urine and serum specimens for each trial.
Attend Investigator Initiation meetings.
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines. Obtain records required to complete case report forms.
Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
Show vigilance in patient safety, protocol compliance, and data quality.
Medidata Rave EDC, DF discover, Veeva Vault EDC.
Collected data and followed research protocols, operations manuals and case report form requirements.
Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials
Neuroscience Pharmaceutical Sales Representative, 01/2010 - 12/2011 Company Name – , , Puerto Rico
Drives sales in assigned territory.
Engages with customers both face to face and virtually.
Develops and implements effective business and territory call plans; effectively identifies and implements live/virtual engagement strategies with customer to maximize overall effectiveness and impact.
Effectively builds rapport and relationships with customers in both live and virtual environments; uses judgment to maintain customer engagement by successfully utilizing existing and ever-changing digital tools effectively for successful customer engagement.
Understands and leverages internal reports and analytics to assist with identifying, developing, and implementing strategic business opportunities.
Compliantly leverages product and disease state knowledge to appropriately educate providers on unbranded and branded product value proposition for relevant patient populations and effectively and strategically utilizes approved clinically oriented disease state information and patient resources, as applicable.
Demonstrates strong teamwork capabilities to collaborate effectively and compliantly across the organization to address customer inquiries and advance Pfizer objectives.
Completes all administrative expectations on time and compliantly.
Visited customer locations to evaluate requirements, demonstrate product offerings and propose strategic solutions for diverse needs.
Identified opportunities and developed business cases to introduce new products and features while learning marketing segmentation processes and optimizing product segmentation for positioning, product bundling, and pricing.
Followed up with customers after completed sales to assess satisfaction and resolve technical or service concerns.
Achieved top performance by strategically adapting to rapidly changing, competitive environment.
Education
M.D.: Medical Internship, Expected in - Memorial Hermann - Houston, TX, GPA: Status -
West Houston Medical Center/St. Joseph Medical Center/Houston Methodist West/St. Michael's Emergency Room/Northwest Surgery Center Red Oak
Bachelor of Science: Human Biology, Expected in - University of Puerto Rico - Bayamon, PR GPA: Status -
M.D.: Medicine, Expected in - Autonomous University of Guadalajara - Guadalajara, Mexico, GPA: Status -
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