Mariam Selvage
Driftwood
Summary
Innovative Oversight Director experienced in converting sales leads and managing multiple accounts. Highly skilled in forecasting, project management and strategic planning with exceptional communication abilities. Thorough in monitoring trends and capitalizing on emerging opportunities.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Associate Director, Oversight
PPD, Inc.
- Current
- Accountable for strategic indication or client-specific portfolio management within a Therapeutic Unit
- Operations subject matter expert in proposal/strategy development yielding a value of +30million of awarded project for fiscal year 2023
- Provides insight into proposal strategy in preparation for bid defense
- Point of contact for sponsor representatives in discussing change in scope, and new opportunities
- Develop case studies for on-going projects for future use in proposal presentations
- Works with Therapeutic Unit Head in development of business growth strategies
- Expertly navigates the need to dive in/dive out of situations while ensuring the functional leads remains empowered
- Provokes critical thinking in leadership of function areas related to execution of delivery, financial negotiations, prioritization
- Communicates with people managers to support the development of employees; and provides expertise and perspective related to client needs, indication, and therapeutic knowledge.
Sr. Project Manager
PPD, Inc
- 08.2021
Project Manager II
Syneos Health
- 04.2019
- Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
- Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations
- Serves as the team leader by overseeing the project team, including the clinical team
- Acts as a liaison and facilitator between other operation departments within the Company for project related tasks and/or issues
- Plans and projects resources required across all areas of the study
- Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses
- Oversees and tracks site payment issues as required
- Alerts Finance on the need for customer invoicing
- Develops and maintains project plans for the study in accordance with SOPs and Work Instructions (WI)
- Performs ongoing review of project financial status of studies within his/her responsibility
- Alerts senior management to potential issues and ensures necessary corrective action is taken
- Independently prepares information for internal review meetings
- Presents prepared information at project review meetings
- Oversees the regulatory document collection and submission process
- Ensures project documentation, including Trial Master Files (TMFs), are complete and audit ready
- Assists in the negotiation and contracting process with outside vendors (labs, printers, etc.)
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools
- Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management
- Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and Customer presentations
- Ensures adequate documentation of each communication
- Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.
Study Manager (Strategic Relationship, EP)
PAREXEL International
09.2015 - 06.2016
- Led cross functional study delivery team in the overall execution of Clinical Pharmacology study (ies), including set-up, initiation, monitoring and close-out in accordance with study objectives, timelines and contract agreements, and in compliance with relevant SOPs, ICH/GCP and other applicable regulatory requirements
- Contributed to / coordinate development of / review of protocol, ICF and subject remuneration, setup of ClinBase / Datalabs / paper CRF / eDC/ database, Statistical Analysis Plan (SAP), specifications, study plans/tools (e.g., PK tube labels, PK sample shipments, pharmacy and/or laboratory manuals, CTM labels)
- Coordinated and ensure completion of process for study insurance
- Managed timely and quality submissions of study documentation to IRB, EC and CA
- Actively participated in study initiation visits and coordinate study specific team training, if applicable
- Monitored subject recruitment and retention to ensure successful outcome of the study
- Conducted regular team meetings to discuss study status, budget adherence, plan activities, identify and address study-related issues
- Proactively identify, communicate, and resolve risks to the study or escalate as appropriate
- Ensured maintenance of accurate and up-to-date information to Sponsor and PAREXEL tracking systems
- Coordinated and participated in Blind Data Review Meeting; review safety and PK/PD TFL's
- Coordinated and participated in clinical study report development
- Oversaw all administrative closeout procedures are completed, including IRB/EC termination, final milestone payments are billed, etc
- Oversaw maintenance and quality check of investigator site files
- Prepared, participated in and follow up on audits/inspections of PAREXEL sites and facilities
- Maintained a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
Project Leader EPD (PL EPD)
PAREXEL International
04.2014 - 09.2015
- Ensured that the Master Service Agreement (MSA), WO and contracts are in place and fully understands the scope of the agreements in order to successfully drive project execution
- Lead client kick off meeting and discussion with client, by establishing client expectations for project delivery, communication, and client specific metrics
- Ensure the scope of the study is well understood by the project team and set the team expectations
- Lead the team kick-off meeting and ensure the scope of the study is well understood by the project team and all functions and that the appropriate resourcing will be delivered by the functions
- Managed the setup of the project team including overseeing request for resources, reviewing proposed team members for suitability, and managing any project team changes throughout the duration of the project
- Ensured development of all relevant systems, tools and templates as per relevant SOPs including a project plan including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, MSP, Communication Plan, Risk Analysis, etc.) and a Monitoring Plan
- Managed Site Start-up activities including conduct of site qualification and initiation visits as per client or project demands
- Monitored study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project
- Oversee maintenance and quality check of Central Files
- Ensured the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations and budget constraints
- Ensured information in management systems and tools is accurate and up to date any time
- Proactively took action where required to maintain project deliverables
- Pro-actively communicated with the client ensuring the client has all the information required on project progress and status (risk analyses, contingency plans, technical information, significant changes of any kind etc.); provide pro-active decisions /solutions and how the project objectives are being, or should be, achieved
- Led team meetings internally and with client on a regular basis to ensure project objectives are met; ensure the on-going communication to team members of the scope of work, timeline and project goals, technical information, and input from client throughout the project including significant changes in resourcing, scope of work and timelines
- Oversaw all administrative closeout procedures are completed, as per relevant SOP
- Ensure project is archived and all documentation returned to the client as specified the by the contract.
Project Manager
PAREXEL International
11.2012 - 04.2014
- Prepared and discussed with Unit Director and with representatives from other business units to identify staff necessary for the study team; request study team resources from the CPRU management team; call the initial team meeting to review the contract and protocol and develop recruitment strategy, working schedule and assignments; provide or arrange for project-related training as needed for team members
- Oversaw the IRB submission process; Prepared for IND submission; Maintain the Clinical Trial Master File
- Assured the study is completed within timelines, budget, schedule, and according to contract specifications; determine the cause of out-of-scope activities, recommend and institute corrective action; hold team meetings on a regular basis for delegation of responsibilities and tasks to team members, monitoring the progress of each individual task, and assessing the overall team members
- Oversee the milestone and monthly pass-through invoicing to client
- Served as primary contact for client’s liaison; communicate to team members the scope of work, timeline and study goals, technical information, and input from clients throughout the study; serve as chairperson for the study team, inform team members of any new information or modification of study-related issues which may affect specific responsibilities of team members; report to line managers any anticipated need for addition or re-assignment of resources, training, or performance issues
- Assisted in all functional areas (data management, biostats, medical writing, PK/PD analysis) of the study as needed, including input and review of the following in team meetings to ensure timeline / quality of program compliance
- Clinical study protocol, Informed consent language and content, Case report form development including performing user acceptance testing for EDC, Data management plan, Data validation plan, Statistical analysis plan, Clinical study report.
- Prepare and oversee the preparation of dose escalation and high-level result meetings to provide all safety/Pk/PD data required to make an informed decision as to the progress of a program.
Clinical Research Coordinator II
Lotus Clinical Research
07.2012 - 11.2012
Laboratory Manager
PAREXEL International
10.2010 - 07.2012
Laboratory Supervisor
PAREXEL International
11.2006 - 10.2010
Clinical Research Coordinator
PAREXEL International
11.2006 - 10.2010
Clinical Research Associate
PAREXEL International
11.2006 - 10.2010
Education
MBA - Concentration in International Business
Texas A&M University
Loredo, TXB.A. - Sociology
California State University Northridge College of Social & Behavioral Sciences
Northridge, CASkills
- EDC Systems (eg, Medidata Rave, CISIV, InForm, Oracle RDC, and etc)
- Project View
- IMedidata CTMS
- ESource Data Capture Systems
- Trifecta
- Plainview
- Veeva Vault eTMF
Certification
- Good Clinical Practice
- Biotech University
Professional References
- Cari Combs., M.D, Senior Medical Director, Medical Management and Scientific Services, Syneos HealthTM, 1030 Sync Street, Morrisville, NC, 27560, 919-985-5918, Cari.d.combs@gmail.com, Dr. Combs and I worked together from 2017 – 2019 on Phase III trial at Syneos Health.
- Hakop Gevorkyan., M.D, Associate Medical Director, PAREXEL International, 195 West Street, Waltham, MA, 02451, 818-486-5996, Hakop.Gevorkyan@Parexel.com, Dr. Gevorkyan and I worked together from 2010 – 2016 on varies programs at PAREXEL International.
- John Nelson., CPA, Sub-Investigator, Lotus Clinical Research, LLC, 100 W. California Blvd #25, Pasadena, CA, 91105, 626-676-0331, Mnvkngs65@hotmail.com, John Nelson and I worked together from 2006 – 2016 on varies programs at PAREXEL International.
Timeline
Study Manager (Strategic Relationship, EP)
PAREXEL International
09.2015 - 06.2016
Project Leader EPD (PL EPD)
PAREXEL International
04.2014 - 09.2015
Project Manager
PAREXEL International
11.2012 - 04.2014
Clinical Research Coordinator II
Lotus Clinical Research
07.2012 - 11.2012
Laboratory Manager
PAREXEL International
10.2010 - 07.2012
Laboratory Supervisor
PAREXEL International
11.2006 - 10.2010
Clinical Research Coordinator
PAREXEL International
11.2006 - 10.2010
Clinical Research Associate
PAREXEL International
11.2006 - 10.2010
Associate Director, Oversight
PPD, Inc.
- Current
Sr. Project Manager
PPD, Inc
- 08.2021
Project Manager II
Syneos Health
- 04.2019
MBA - Concentration in International Business
Texas A&M University
B.A. - Sociology
California State University Northridge College of Social & Behavioral Sciences
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