Medical Communications manager

Company: Eteam Inc
Location: West Chester
Posted on: April 24, 2024

Job Description:

*NIT1*About the companyeTeam was formed in 1999 with the goal of becoming the company of choice for clients, talent and staffing professionals. Today, were one of the fastest-growing global companies and ranked as one of the best companies to work for by Staffing Industry Analysts. We aspire everyday to do quality work for our clients and help our talent work at some of the most amazing companies.*Job Title - - Medical Communications manager**Duration 6to 12 Months**Location: West Chester, PA Hybrid Role **Payrate: $55/hr on w2**# Of Positions: 01**Job Description*:*Primary purpose and function of this position:*The primary responsibility of the CPM is to oversee and manage Non-Interventional Studies (NIS) for Global Medical Affairs(GMA) and North America Medical Affairs (NAMA). This includes phase 4 observational regulatory mandated post-approval safety studies (PASS) as well as scientific communications including publications to support medical evidence generation/ payers (i.e. Real World Evidence Trials).*Major duties and responsibilities:* Management, maintenance and coordination of the logistical aspects of studies, supporting the Accociate Director. Etablishes and manages the cross-functional internal meetings from study start to the study report. Collaborates with Global Procurement, Pharmacovigilance, and other relevant functions such as Statistics, medical affair representatives, etc., to identify and select a CRO/vendor In collaboration with Legal and Global Procurement, contracts with the CRO/vendor according to the Global Procurement Policy. Reviews and approves contracts direct and indirect fees of final proposals Participates in the review of the protocol, providing suggestions for a protocol change to responsible author on behalf of Global Clinical Operations and ensuring consistent with Good Pharmacovigilance Practice (GVP)/ Good Pharmacoepidemiology Practice (GPP), and Standard Operating Procedures (relevant SOPs etc.), as applicable Ensures all study related manuals/plans are completed and revised as needed Establishes any study specific template (site contract, budget, etc) at the start of study, in coordination with legal and any other applicable cross-function team members. Mitigates any site level or country level contract/budget sponsor elevations. Reviews and approves protocol related (ICF/Monitoring /CRF's/e-CRF's) documents Establishes the study budget with assistance from finance and in collaboration with the study team Prepares recruitment projection and selects countries and sites in collaboration with the study team, in collaboration with medical affairs.. Oversees CRO/vendors activities according to the contract and the project plan. Manage the meetings with the CRO at the study level Manages the study budget and ensures accurate and timely payment of invoices to the CRO and vendors Plans and manage investigators and Kick-off meetings in close collaboration with the Study Leader and the study vendors Ensures that training and applicable Sponsors information and/or materials are provided to all CRO/vendor personnel participating in the conduct of the study In case of premature study termination or temporary suspension, leads the appropriate follow-up, ensures the study termination plan and distribution to the CRO/vendor is accomplished inline with the applicable Sponsors SOP and regulatory and public relations requirements Ensures that all essential documents are present and that the TMF is complete prior to transfer to Client Provides the Medical Affair /Study Lead with regular updates that include progress on recruitment, risks and mitigation, timelines, data collection, quality, and spend vs. budget information Participates in the review, development and revision of departmental SOPs Leads or Participates in Training needed for the CRO/Vendor Ensures compliance with Quality standards (SOP's, Good Clinical Practices (GC), Guideline on Good Pharmacovigilance Practice (GVP), ICH harmonized tripartite guideline Pharmacovigilance Planning E2E (ICH, 2004), ; Good Pharmacoepidemiology Practice (GPP), regional/local country regulations; and Standard Operating Procedures (relevant SOPs etc.) Develops in-depth knowledge in relevant indications and non-interventional/PASS methodology Any other task assigned by direct manager*Competencies:* Strong communication and organizational skills Strong management and motivation skills Ability to manage study teams and perform issue escalation Flexible and able to work with deadlines Teamplayer who can also operate alone Solution-oriented and problem solving attitude Vendor/CRO and budget management skills Knowledge of study budget management and patient fees*Education and Knowledge Requirements:* Undergraduate/BSc degree or higher in applicable discipline and 5-7 Yrs of related experience Experience in late phase/non-interventional research At least 4 years of experience pharmaceutical industry or clinical research site based experience. Knowledge of ICH GCP, GVP and GPP guidelines Monitoring experience preferred Must be able to travel with overnight stays, as necessary, travel up to 5% Computer literate Fluent in EnglishJob Type: ContractPay: Up to $55.00 per hourSchedule:* 8 hour shiftWork Location: In personby Jobble

Keywords: Eteam Inc, Wilmington , Medical Communications manager, Executive , West Chester, Delaware