Senior Clinical Project Manager (Dermatology)

TFS Research Triangle , NC 27709

Posted Yesterday

TFS HealthScience is excited to be expanding our Project Management team and we are looking for an experienced, highly motivated Senior Clinical Project Manager (SCPM) who shares our vision of providing clinical research excellence. Our Project Management team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference. The Senior Project Manager will have the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.

TFS HealthScience is looking for a Senior Clinical Project Manager (SCPM) home based in the US. We look forward to receiving your application!

The Senior Project Manager will plan and pro-actively manage multidisciplinary study teams (including Site Management, Data Management, Statistics, Medical Writing, Regulatory and Safety) to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - quality standards.

The Senior Project Manager may assist Project Managers in the identification of critical project task/issues and recommend course of actions to expedite project objectives and function as a project senior-level governance contact for issue escalation matters.

Key Responsibilities

  • Ensure that projects are delivered on-time, within scope and within budget and in compliance with applicable quality standards
  • Manages the strategic aspects of projects and identify, analyze and minimize/mitigates any risk, including the implications of difference technical and operational choices.
  • Mentor and coach for PM when needed
  • Communicates effectively with clients to successfully manage the relationship, identify needs and evaluate alternative business solutions and strategies.
  • Develop and maintain Project Plans and timelines for their project and track progress
  • Ensure all study team members are adequately trained on project specific systems and procedures
  • Manage the resource allocation, on the project, in collaboration with respective line managers
  • Establish and maintain relationship with third parties/vendors
  • Participate in capability presentations/bid defenses, as needed
  • May provides leadership, guidance and support for Business Development opportunities, including participating in business proposal generation and final review process.
  • Contribute in review/develop procedures, guidelines, SOPs, metrics as needed

Requirements

  • Bachelors Degree, preferably in life science or RN diploma
  • 5 year of relevant experience
  • experience working in Project Management in Dermatology clinical trials
  • In depth knowledge of clinical research regulations governing the conduct of the clinical trials and quality standards
  • In depth knowledge of project planning and metrics
  • Demonstrated ability to lead and manage staff

Benefits

What can we offer you?

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. United States benefits include:

  • Competitive salary & benefits package
  • Excellent career progression opportunities
  • Great corporate culture and work life balance
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Operations Lead

G1 Therapeutics

Posted 2 months ago

VIEW JOBS 9/3/2022 12:00:00 AM 2022-12-02T00:00 <p>The Company:</p><p>Our mission is to improve the lives of people impacted by cancer by developing and commercializing innovative cancer therapies. We know how a cancer diagnosis affects a person and their family, and we are driven every day to improve outcomes for those who have received the diagnosis. We do this by driving adoption of our first FDA-approved breakthrough drug for appropriate patients with extensive-stage small cell lung cancer and by developing our robust, late-stage clinical pipeline assessing the potential for our medicine in a variety of tumors and cancer treatment settings.</p><p>Our strategy leverages the experience of the G1 team and our deep experience in inventive and responsible drug development and commercialization. G1 provides a professional, diverse, inclusive, and creative working environment where individuals can thrive. We are driven to succeed by the patient communities we seek to help. We offer an opportunity to bring your best every day, and in doing so, profoundly help people living with cancer. Patients are waiting.</p><p>The Opportunity:</p><p>G1 Therapeutics is currently recruiting a Clinical Operations Lead to join our team in Research Triangle Park, NC (our HQ is operating on a hybrid in-office/remote model), reporting to the Director of Clinical Operations. The Clinical Operations Lead plays a significant role in the successful execution of G1 Therapeutics clinical trial portfolio. If you are looking for an opportunity to be a part of team that collaborates, strategizes, and seeks to execute with excellence, then this opportunity is just what you're looking for.</p><p>Responsibilities:</p><ul><li>Participate in internal and external team meeting, submit agenda items for meetings, serve as resource to CTA in preparation of agendas, meeting minutes, and ensuing team updates. May lead the internal team meetings as delegated by the Study Manager</li></ul><ul><li>Partner with the CRO (with oversight of the Study Manager) for draft/review/approval of the development, assembly and distribution of study documents, manuals and tools.</li></ul><ul><li><p>Work closely with Manager/Sr. Manager/ Director or higher regarding key elements of CRO study execution: 1-all areas of study start up 2-ongoing site monitoring, to include trip report review, initial protocol questions 3-partnering with DM function to track and monitor data currency, query resolution timelines and data trends</p></li><li><p>Review/Approve site specific essential documents from CRO to authorize release investigational product (IP) for study conduct</p></li><li><p>May be asked to review and provide feedback as needed to key study documents, such as Study Protocol, Amendments, Investigator's Brochure, DSUR, IMPD, CSR, etc. under the direction of the study manager or other Clinical Operations staff</p></li><li><p>Track and prepare study- specific information/ reporting as relevant to study start up activities and clinical monitoring or other items as requested by the Study Manager or Director</p></li><li><p>Review KPI/Metrics from CROs and partner with the Study Manager in analysis and subsequent distribution to the team</p></li></ul><ul><li>May be delegated the responsibility for the development of the study template Informed Consent Form (ICF) document, updates to the ICF</li></ul><p>Requirements:</p><ul><li><p>The candidate must have a BA/BS degree or equivalent; health science degree or biologic science degree is preferred.</p></li><li><p>A minimum of 5 years' experience in the pharmaceutical industry, a combination of monitoring and Lead CRA roles is preferred.</p></li><li><p>While not required, Oncology experience is a plus.</p></li><li><p>This role is to be based out of G1 Therapeutics office in RTP.</p></li><li><p>Up to 25% travel may be required.</p></li></ul><p>Why Join Us?</p><p>We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.</p><p>An Equal Opportunity Employer</p><p>G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.</p><br> G1 Therapeutics Durham NC

Senior Clinical Project Manager (Dermatology)

TFS