Senior Clinical Project Manager

Stryker Corporation Nashville , TN 37201

Posted 2 months ago

Job Description:

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Clinical Project Manager to join our Neurovascular Division to be located remotely anywhere in the United States.

Stryker's Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to "Make Stroke History". Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: [ Link removed ] - Click here to apply to Senior Clinical Project Manager.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As the Senior Clinical Project Manager, you will manage multiple aspects of clinical operations for assigned clinical trials/product lines to assure the highest standards of clinical study execution. You will be responsible for managing all aspects of a clinical trial or multiple clinical trials including CRO & vendor selection and oversight to ensure patient safety, adherence to the contract, protocol and appropriate safety regulations and data integrity, provides oversight and mentorship to clinical project managers. You will ensure compliance to SOPs, organize and lead CRO/vendor meetings, maintain study timelines, and provide study updates to internal line functions and management team.

  • Provides oversight and leadership to fellow project managers.

  • Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.

  • Serves as primary contact and resource for Lead CRA, CRO and vendor personnel. Supports selection and provides oversight and management of consultants and vendors.

  • Tracks and reports on the progress of assigned clinical trials including budget and timelines.

  • Executes project plans including management of schedule, cost, resources and deliverables (e.g. protocol, database development, reporting).

  • Develops project plans and ensures adherence to budget and timelines.

  • Leads various teams (including CRAs, CTCs, Data Management, Biostats) to create and manage study related documents.

  • Oversees data management and analysis to ensure quality of clinical trial data.

  • Oversees data clarification process as needed to insure database lock according to agreed timeline.

  • Maintains up to date knowledge of published literature in relevant therapeutic areas including a broad awareness of neurovascular issues.

  • Co-monitors with Monitors to evaluate and ensure quality of Monitoring Team. Ensures that studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations and departmental SOPs.

  • Ensures appropriate oversight of CRO and vendors.

  • Organizes and participates in meetings - i.e. Study Team Meetings, Investigator Meetings, Monitors' workshops, and Team Training.

  • Leads the preparation of clinical documents in support of regulatory requirements including IDEs, IDE and IRB annual updates, briefing documents, CTAs, as requested.

  • Provides input and review of the development of in-house operations SOPs, guidelines and systems.

  • Develops and maintains positive relationships both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators).

  • Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable Stryker SOPs and policies.

  • Proactively identifies risks and leads team members to mitigate risks in timely fashion.

  • Manage the triage of clinical site questions to appropriate team members (Program Manager or Director as appropriate).

  • Prepares and manages clinical trial site budgets.

  • Fully supports the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

What you need

  • A minimum of a bachelor's degree (B.S. or B.A.) or experience as a Medical Healthcare Professional required.

  • Certified Clinical Research Associate (CCRA) preferred.

  • Project Management Professional Certification preferred.

  • A Master's degree in business management preferred.

  • A minimum of 8 years of experience in all operational aspects of managing clinical trials with studies conducted under US Regulations required.

  • Proficiency in resource planning and clinical trial financial management required.

  • Must have a demonstrated working knowledge of GCP,, ICH guidelines, and FDA regulations required.

  • Experience monitoring medical device studies preferred.

  • Strong leadership and management skills preferred.

  • Previous experience within a Sponsor organization or a Clinical Research Organization required.

Work From Home: Remote

Travel Percentage: 30%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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

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
Senior Clinical Project Associate


Posted 7 days ago

VIEW JOBS 11/19/2020 12:00:00 AM 2021-02-17T00:00 SHIFT: No Weekends SCHEDULE: Full-time Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is committed to oncology. We offer a strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology. We work with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows us to offer sponsors access to a diverse and dynamic patient population, spanning multiple tumor types and disease stages. These relationships further improve the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to state of the art therapies for those facing cancer in communities across the United States and United Kingdom. Benefits: * Tuition Reimbursement/Assistance Programs * Paid Personal Leave * 401k (100% annual match - 3%-9% of pay based on years of service) * Identity Theft Protection discounts * Auto, Home, and Life Insurance options * Adoption Assistance * Employee Stock Purchase Program (ESPP) As the Senior Clinical Project Associate you will be responsible for providing project level support to Project Managers and Clinical Team Leads. You will ensure all trial related documents are collected and reviewed throughout the life cycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools. You will actively participates in cross-functional teams to ensure delivery of project deliverables. You should be a proactive member of the study team to ensure that all study team members are aware of required deliverables including study team training, required site documents, or other study related documents. Additionally, you are responsible for mentoring new team members and actively participating in process improvement efforts on behalf of the department. You will assume responsibility for complex tasks and applies creative and effective solutions where needed and identify tasks and/or issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing priorities. * You will work independently and serve as a leader within the department and across Development Innovations * You will assist in mentoring and training new CPAs as well as other colleagues within Development Innovations * You will help create, maintain and deliver new CPA onboarding/training * You will conduct functional area overviews for new colleagues * You will initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects * You will lead and participate in cross functional process improvement initiatives * You will support most complex trials held within the portfolio * You will set-up, document collection/upload of files to the TMF/eTMF * You will perform initial quality review of documents prior to upload/filing in the TMF/eTMF * You will partner with document specialist to maintain the Trial Master File (TMF) in "audit ready" condition from study start to completion * You will assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial * You will perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues * You will review study documents to ensure they are current, complete and accurate * You will maintain and distribute study specific documents and materials to study team and investigative sites (i.e. Study Reference Manuals, Contact lists, Vendor Manuals, etc.) * You will study and investigative site set up and data entry within the clinical trial management systems (CTMS) and tracking tools (i.e., Medidata, Sponsor CTMS per scope of work, etc.). * You will grant and revoke systems access (i.e., Medidata, Electronic Data Capture, mySCRI Sponsor Sites Portal, etc.) * You will assist the study team with preparation for audits and inspections of the TMF * You will archive TMF at the direction of the study team * You will generate reports from CTMS * You will track study specific training * You will assist in tracking samples, patient info or other required deliverables to assist the CTL * You will understand assigned protocols and study specific plans as assigned * You will proactively identify gaps in document collection, training and other critical deliverables, develops and action plan for retrieval and escalates as appropriate * You will create meeting agendas and minutes * You will coordinate team conference calls and assist with on-site meeting preparation and closure * You will attend project meetings, conference calls and monthly staff meetings as required on assigned projects * You will communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management * You will adhere to professional standards and SOPs established for clinical research Qualifications You should have for this position: * A High School Diploma; A Bachelor Degree is preferred * Knowledge of clinical research and terminology * Knowledge of ICH GCPs * Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, MS Access or Excel * Highly organized; ability to handle multiple priorities efficiently * Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment * Excellent interpersonal skills, detailed-oriented and meticulous * Ability to work in a complex matrix environment * Strong conflict resolution abilities * Research Professional Certification - CCRP or exam eligibility is preferred Do you want to be a team fighting cancer together? Apply now to hear more about this opportunity. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Notice Our Company's recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, let us know by clicking here. For questions about your job application or this site please contact HCAhrAnswers at 1-844-422-5627 option 1. Apply Now Register Now HCA Nashville TN

Senior Clinical Project Manager

Stryker Corporation