Expired job

Just missed a job?

Sign up and never miss an opportunity again!

EDS Clinical Team Manager job

PRA Health Sciences jobs

Company

Salary

Skills

Job Description

Responsibilities

The Clinical Team Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The CTM leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted ccountabilities may or may not apply.

Provides Project Oversight and Leadership for Clinical Deliverables:

  • Leads and manages the start-up and clinical teams
  • Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.
  • Works with the team to set priorities
  • Takes the initiative to make things happen and leads and supports the relevant staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters
  • Motivates the clinical team
  • Ensures effective communication plans are place for the clinical team
  • Ensures effective escalation plans are in place for the clinical team
  • Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication for proactive, study-wide problem solving regarding study progress and trial issues during the study
  • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
  • Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues
  • Identifies opportunities to improve training, execution and quality control across the team
  • Liaises with relevant staff to provide data as required for clinical operations performance metrics and project status metrics
  • Works with the relevant staffto identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
  • Attends Executive Project Status Reviews as required
  • Project Resourcing

  • Works with the relevant staff (including Director of Project Delivery (DPD) when applicable) to ensure all Clinical team members are adequately assigned to the project
  • Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activities throughout the project duration Actively monitors initial and ongoing clinical resource and identifies/escalates issues to the Project Manager (PM)and/or Clinical Management when applicable
  • Liaises with Clinical Operations Managers to resolve clinical resource and performance issues
  • Disseminates and agrees forecasted activities/FTE to all key team members
  • Oversees transition plans to allow seamless transition of knowledge in case of CTM or clinical team member replacement
  • Quality – Training & Development

  • Creates and maintains project specific plans, documents and tools for the clinical team.
  • Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinical project specifics
  • Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies.
  • Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable.
  • Ensures all PRA project reporting systems are up to date for clinical activities at the project level
  • Oversees the CSS, GRAL, LRAL and IHCRA to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
  • Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
  • Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.
  • Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems
  • Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
  • Project Finance

  • Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget; monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).
  • Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget
  • Ensures that forecasted units are achieved as planned and within the budgeted FTE
  • Identifies out-of-scope tasks from clinical team and escalates as required
  • Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff.
  • Customer Relations (Internal & External)

  • Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved
  • Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required
  • Participates in client meetings, assisting with presentations as required
  • Contributes to Business Development activities participating in proposals and bid defenses as needed
  • Performs any other duties required to ensure the success of the trial and/or PRA
  • Qualifications

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; alicensed health-care professional (i.e., registered nurse); or equivalent work experience required.
  • 5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
  • 2+ years monitoring experience preferred
  • Experience in managing all trial components (start-up to database lock) preferred
  • Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred
  • Read, write and speak fluent English; fluent in host country language required.
  • Estimated annual salary
    $80,478
    average
    Minimum
    $63,669
    Maximum
    $150,565

    TASKS

    • Develop and maintain computerized record management systems to store and process data, such as personnel activities and information, and to produce reports.
    • Direct, supervise and evaluate work activities of medical, nursing, technical, clerical, service, maintenance, and other personnel.
    • Direct or conduct recruitment, hiring, and training of personnel.
    • Develop and implement organizational policies and procedures for the facility or medical unit.

    SKILLS

    • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
    • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
    • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
    • SpeakingTalking to others to convey information effectively.

    KNOWLEDGE

    • Administration and ManagementKnowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
    • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
    • Economics and AccountingKnowledge of economic and accounting principles and practices, the financial markets, banking and the analysis and reporting of financial data.
    • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.

    PRA Health Sciences

    Type

    Company - Public

    Size

    Large

    Revenue

    $100M to $500M

    Location

    Raleigh, NC, and others

    Industry

    Pharmaceutical/Bio-tech

    Founded

    1976

    CEO

    Colin Shannon

    Job Filters

    Information Technology Support TechnicianPRA Health SciencesRaleigh, NC
    Overview: Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 18,000+ employees strong, operating in more than 90+ countries. We are...Read more
    In-House CRA 2 - SeattlePRA Health SciencesSeattle, WA
    Overview Who are we? We Are PRA. We are 17,000 employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are...Read more
    Overview Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 17,000 employees strong, operating in more than 85 countries. We are...Read more
    Overview Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 17,000 employees strong, operating in more than 85 countries. We are...Read more
    Overview Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. Who are we? We Are PRA. We are 16,000 employees strong, operating in more than 85 countries. We are...Read more

    Closed Job Filters

    Clinical Data ManagerPRA Health SciencesDe Land, FL
    Overview Who we are: Over 470 PRA Biometrics resources currently in FTE Programs across 12 global clients Have grown over 40 FTEs in 2018 and continuing to expand 88% global team retention in 2018Read more
    Account Services Manager, in office in Blue Bell, PA on average 2 days per week, remote and onsite with local clients the remainder of the week Our Account Services Manager is responsible forRead more
    Overview We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability toRead more
    Senior Contracts and Grants AnalystPRA Health SciencesAllakaket, AK
    Overview Do you want to be responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizingRead more
    Overview Do you want to be responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizingRead more
    Similar jobs in the area
    Compassionate Clinical Director Needed! BAART services is dedicated to providing individualized treatment integrating pharmacotherapy, clinical counseling, recovery support and medical services. BAART, addiction treatment programs deliver medically...Read more
    Summary The Clinical Director oversees quality functions in Maximus’s Clinical Services Division, which performs a wide array of clinical assessment services for individuals with physical and/or mental disabilities seeking Medicaid-funded services and...Read more
    Clinical DirectorBroadstep Behavioral HealthRaleigh, NC
    COMPANY BACKGROUND: Broadstep Behavioral Health, Inc. (“Broadstep”) f/k/a Phoenix Care Systems, Inc., is the parent company of Broadstep Academy, Inc. and Broadstep Pharmacy. Broadstep has been a leader in providing a continuum of physical, emotional, and...Read more
    360care is the largest provider of healthcare services to nursing homes and assisted living facilities in the United States. We have a mission to better the lives of the residents we serve. Currently we service over 3200 facilities in 20 states and have...Read more
    flexjobs
    Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends—it's up to you. Earn Good Money. You’ll earn by bringing people the food they love from local restaurants. Choose...Read more
    Clinical Advocacy & Support has an unrelenting focus on the customer journey and ensuring we exceed expectations as we deliver clinical coverage and medical claims reviews. Our role is to empower providers and members with the tools and information needed...Read more
    Welcome to the UNC Health Career site! We have been hard at work to improve our job searches and application systems to better serve you. It will now be easier to find and apply for jobs as well stay connected with UNC Health. Here are a few of the updates...Read more
    PROGRAM DIRECTOR - CLINICAL AND TRANSLATIONAL SCIENCE AWARD (CTSA) Requisition Number: 75328 Date: Nov 19, 2020 Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER School of Medicine: Established in 1930, Duke University School of Medicine is...Read more
    At ICON, it's our people that set us apart. As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire...Read more
    ViiV Employees Receive 100% of GSK's Total Rewards and Benefits! ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly...Read more
    Job descriptionPURPOSEClinical Leadership is focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction. Focus is on leveraging clinical operations and therapeutic expertise along with the...Read more
    Show more jobs
    500+ more jobs

    Similar jobs

    Clinical Lead DirectorIQVIA ArgentinaDurham, NC
    Primary Location: Durham, North Carolina, United States Full time R1170183 Date Posted: 01/05/2021 PURPOSE Clinical Leadership is focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction...Read more
    Director, Clinical DevelopmentGSK PolandDurham, NC
    Research Triangle Park, North Carolina; Brentford, United Kingdom Medical and Clinical 268577 Job description Site Name: UK - London - Brentford, USA - North Carolina - Research Triangle Park Posted Date: Oct 29 2020 ViiV Employees Receive 100% of GSK's...Read more
    Clinical Lead DirectorIQVIA Holdings IncDurham, NC
    PURPOSE Clinical Leadership is focused on the delivery and quality of the contracted Clinical services within a project to achieve customer satisfaction. Focus is on leveraging clinical operations and therapeutic expertise along with the diverse IQVIA...Read more
    Director, Clinical OperationsMix-TalentDurham, NC
    The Director of Clinical Operations is accountable for the operational strategic planning, oversight and delivery of assigned clinical programs in accordance with ICH, US regulations and internal ...Read more
    Overview The Director of Clinical Development is responsible for the planning, implementation, and renewal of affiliation agreements with all agencies supporting clinical experiences for students. The Director of Clinical Development is responsible for...Read more
    Duke University Hospital is consistently rated as one of the best in the United States and is known around the world for its outstanding care and groundbreaking research. Duke University Hospital has 957 inpatient beds and offers comprehensive diagnostic...Read more
    Director of Clinical DevelopmentMedical Careers InstituteRaleigh, NC
    Overview The Director of Clinical Development is responsible for the planning, implementation, and renewal of affiliation agreements with all agencies supporting clinical experiences for students. The Director of Clinical Development is responsible for...Read more
    Director, Clinical MonitoringClinipaceMorrisville, NC
    Job Title: Director, Clinical Monitoring Job Location: Morrisville, NC (Remote) or any US Remote Location Job Overview: Supervises and is responsible for the growth and development of a group of CRAs and/or CTMs. Assumes a leadership role in the oversight...Read more
    Acadia Healthcare provides behavioral health services to its patients in a variety of settings. We currently have an opening for a Director of Clinical Services in a residential setting located in North Carolina. This position is responsible for ensuring...Read more
    Director-Clinical ServicesCamp RecoveryHolly Springs, NC
    Acadia Healthcare provides behavioral health services to its patients in a variety of settings. We currently have an opening for a Director of Clinical Services in a residential setting located in North Carolina. This position is responsible for ensuring...Read more