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Clinical Trial Liaison Medical Affairs
LE004 Amplity Inc Pennsylvania, PA
$70k-96k (estimate)
Full Time Just Posted
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LE004 Amplity Inc is Hiring a Remote Clinical Trial Liaison Medical Affairs

Come join the true partner of global healthcare companies, Amplity Health. We continually challenge the boundaries of medical and commercial strategies to accelerate the approval and launch of new drugs to improve the lives of patients. Clinical Trial Liaison Medical Affairs Immunology Site Relationship Leader Candidate Desired Residence: Ohio, Illinois, or Pennsylvania Initial Site Locations: CT, IL, MA, MI, MN, MO, NY, OH, PA Expansion Based upon the success of our current global medical affairs team, we will be adding an additional US position. Amplity has an exciting opportunity with one of our leading global pharmaceutical clients. The Immunology Site Leader (ISRL) will support enrollment of patients into clinical trials, acting as a liaison between sponsor and study sites. As an Amplity employee you will enjoy a competitive base salary, additional bonus potential, auto allowance, full benefit package including 401K, generous PTO, medical, dental, vision, paid holidays and more. We are looking for a LOCATIONS ISRL Residence near a major airport desired. ISRL will be responsible for executing site engagement strategies to enhance patient identification, screening, and enrollment activities. The ISRL shall endeavor to achieve these objectives by fostering PI and study site ongoing awareness of the clinical trials via in-depth clinical, scientific, and educational discussions as it relates to the applicable clinical trial protocol, including discussion of the inclusion and exclusion criteria and correct clinical study patient profile. Collaborating with Site Start Up/Site Activation/Clinical Leadership teams to support “Ready to enroll” status of site is expedited in line with program expectations. While engaging with clinical site staff, the ISRL will use only materials and education provided by Company. The ISRL does not engage with patients, nor does the ISRL perform a regulated function. The ISRL will engage with an estimated 15 study sites, or several study sites as mutually agreed upon by the parties, throughout the duration of the study. Key Accountabilities: Day to day activities and responsibilities: Attend a site qualification visit and/or site initiation to support site training and establish a relationship with the site (where applicable) Assist site in completion of feasibility requirements including site investigator profile questionnaire (where applicable) Develop site engagement plans and modify as needed throughout the trial by establishing regular check-in connection with each assigned site based on need (minimally 1 teleconference/visit/email every 3-4 weeks based on site responsiveness) in collaboration with the study Clinical Research Associate (“CRA”) Adapt study engagement strategy to country level action plan including portfolio/study messaging for enrollment after consultation and approval with Sponsor Be a member of country site engagement team to create country specific action plans and solutions supporting the immunology-rare disease portfolio Provide alignment and coordination while partnering with all study team stakeholders (Medical Science Liaison (“MSL”), Therapeutic Area (“TA”), Clinical Research Organization (“CRO”) counterparts, Clinical Trial Managers (“CTMs”), and local teams to create a strategic relationship with the site. Ensure requests received from Principal Investigators (“PIs”) and/or site study staff are managed efficiently and effectively according to established processes Gather insights on site progress as documented by the protocol for patient finding and identification and develop relationships to enhance Support sites in development of referral networks. Encourage site to enhance referral network by building relationships with healthcare providers (“HCPs”) who have the potential to refer to the study site by providing approved materials to arm the site to support referral network Ensure all site engagement discussions are tracked in designated Sponsor system. Review feedback from all contacts to identify country and site level trends or opportunities noted immediately prior to and within 48 hours of each engagement Follow up within urgent requests within 24-48 hours, less urgent inquiries within 1 week Liaise closely with the relevant site study team members to gather insights into key performance indicators (“KPIs”) and site performance Attend bi-weekly meetings with Company and CRO to discuss trial progress and deliver insights on site status. Attend investigator meetings to support sites Identify and attend industry meetings with Company approval for the purpose of enhancing investigator engagement. As part of self-development, you are expected to keep up to date with clinical knowledge, published data and competitive product studies Complete mandatory training (both study specific & company specific) in assigned timelines upon hire Coordinate best practice and key learnings across sites Cross Functional Collaboration Carefully gather insights and information from PIs and report back to company to help develop clinical strategy via CRM tool Work closely with . Clinical, CRO, Medical Affairs and other internal groups to communicate the output of the teams’ activities and sharing of information Review CRO information on site status and site requests Compliance Operate in a highly ethical manner and comply with all laws, regulations, and policies Complete mandatory training and refreshers in assigned timelines upon hire, as well as, when new policies, SOP’s, guidance are issued Raises questions to management and compliance around any areas of uncertainty Essential Knowledge and Experience Bachelor's degree from an accredited university required. Terminal degree a plus 4 years with relevant experience in pharmaceutical, clinical, or medical industry Immunology or Rare Disease experience a plus MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience e.g., CRA (Clinical Research Associate) preferred, with clinical trial background a plus Patient enrollment experience advantageous Knowledge of and relationships with strategic site/networks is preferred Experience with clinical trial design, conduct and evaluation. Clinical trials experience and understanding of clinical trial methodology and management Experienced with Microsoft Word, Excel, and PowerPoint Excellent technical skills with meeting platforms including Zoom, Teams, and other software packages Ability to work within the relevant National Pharmaceutical Codes of practice Other duties and responsibilities as needed Travel weekly as needed Valid driver’s license and safe driving required Essential Skills: Strong written and verbal communication skills, ability to present medical/scientific information in a clear and concise manner Networking skills and confidence to interact with senior experts on a peer-to-peer level Skills to identify, develop, maintain, and build advocacy with strategic sites/Networks Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to assimilate information quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with clinical development strategy Self-directed; able to work with limited supervision, and contribute to team objectives Develops reports and analyses setting forth progress, roadblocks, and appropriate recommendations for project success/conclusions Ability to function well, both independently and within a team setting, in a dynamic, fast-paced environment Project management skills – to deliver on complex tasks within timeframe and manage milestones Experience of working in a matrix management environment, able to prioritize and orchestrate matrixed teams to drive approaches to success Ability to drive innovation and solve problems in an ambiguous environment Highest ethical standards Values These are our company values that we expect all candidates and potential employees to embody as these values strongly underpin our culture: Excellence Passion Integrity Innovation Collaboration Colleagues in customer-facing roles within our Commercial and Medical Solutions teams may be expected to maintain required credentials, including vaccination status. This ensures compliance with standards for patient and colleague safety. #MSL, #MedicalScience Liaison, #ClinicalTrialsLiaison, #CTL, #InvestigatorSites, #InvestigatorStudies ABOUT US We have a 40-year track record of delivering solutions for Pharma and Biotech companies large and small. Our wide-ranging capabilities include clinical and medical outsourced teams; clinical and medical capability development; companion diagnostic and precision medicine solutions; medical communications; expert engagement; remote and field solutions for patients, payers, and physicians; and strategic and access consulting. Therapeutically, we cross many areas but have been a leader in oncology and rare diseases. Our one-of-a-kind Insights database offers clients a detailed view into patient–provider interactions and provider treatment rationale not found through any other provider. Every offering, every touchpoint, every solution is designed to ensure our pharmaceutical client’s patients gain access to and benefit from the best medicines for the right reasons. OUR CULTURE Our company values align to our partnership vision and define our culture. These EPIIC values are reinforced in our people, our processes, and the solutions we provide for our clients: Excellence, Passion, Innovation, Integrity, and Collaboration. We believe that delivering on true partnership for our clients begins and ends with our own team, which is why we relentlessly recruit and maintain teams devoted to living our EPIIC values. The result? An inclusive, collaborative, and respectful culture we are proud of. We hold one another accountable to maintaining a safe workspace where we challenge one another to bring our best selves to work each day. You will never feel unsure about how our EPIIC values look when lived out. We make conscious efforts to model and reward behaviors that remind our colleagues, clients, vendors, and partners what we stand for. We foster a sense of belonging by ensuring contributions are heard and respected. We want every member of the team to feel like they have a voice and they can use it. Constantly challenged and always supported, each member of our team is empowered to create innovative, meaningful outcomes for our clients. Opportunities with Amplity offer competitive compensation and dependent on the opportunity could include a comprehensive benefits package and 401K benefits. To learn more about us, visit our website at amplity.com or our social media pages, linkedin.com/company/amplity-health and twitter.com/amplityhealth. CELEBRATING DIVERSE PERSPECTIVES We passionately champion a culture of belonging, with transparent company practices that drive diversity, equity, and inclusion. Our commitment to inclusion is core to who we are. We welcome people with diverse backgrounds and perspective who ignite curiosity and challenge the status quo. As a provider of services across 6 continents, our team is as diverse as the clients we serve and the countries we work in. We seek to create an inclusive, fair, and respectful environment that celebrates the individual differences and unique perspectives each person brings; where everyone feels a sense of belonging and can be their true, authentic, and best self. As an equal opportunity employer, we welcome everyone to our team. We promise to maintain a safe working environment where team members can thrive. The IDEA – Amplity’s Inclusion, Diversity, and Equity Alliance – makes sure of it. The IDEA helps our organization embrace diverse business practices, creates a sense of community through colleague resource groups, reminds our leaders to sponsor and embrace diversity, equity, and inclusion, and encourages cultural competence and awareness through company-wide resources for learning. Our commitment to diversity spans our people, our processes, and our suppliers. OUR DIVERSITY POLICY We encourage and support equal employment opportunities for all associates and applicants for employment without regard to sex, race, color, religion, national origin, age, disability, marital status, sexual orientation or veteran status. Employment decisions are evaluated on the basis of an individual's skills, knowledge, abilities, job performance and other qualifications. In addition, Amplity Health maintains policies and procedures designed to comply with applicable federal, state and local laws governing non-discrimination in employment in every location in which Amplity Health has facilities.

Job Summary

JOB TYPE

Full Time

SALARY

$70k-96k (estimate)

POST DATE

05/03/2024

EXPIRATION DATE

07/01/2024

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