Artech Information Systems, LLC Excellent Job Opportunity for the position of Senior Site Manager (6308684) in East Hanover, New Jersey
Reference # : 17-02301 Title : Excellent Job Opportunity for the position of Senior Site Manager (6308684)
East Hanover, NJ
Position Type : Contract Experience Level : Start Date / End Date : 02/06/2017 / 02/06/2018
Description Job Title: Senior Site Manager
Work Location: Remote Location
Length of Assignment: 12 Months
Client: A Big Pharmaceutical Company
Regional Site Managers (CRAs) support the goals of the Gen Med organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Client's SOPs and ensuring that study milestones are met. Central point of communication between Client's and investigational sites for all clinical trial related activities. Mentor to CRAs. Trial Lead CRA role when assigned. Performs additional roles and functions for US ICRO as assigned; such as participating/leading special project initiatives and committees. Is an essential contributor for the assessment and development of processes.
** REMOTE positions.
Regional Site Managers (CRAs) needed for the following locations:
• Los Angeles – 2
• Boston/NY area
• Washington DC -2
• Richmond, VA
• Charlotte, NC
• Miami/Ft. Lauderdale/West Palm Beach
• Seattle/Portland/San Francisco
• Support the goals of the Gen Med organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Client's SOPs and ensuring that study milestones are met.
• Central point of communication between Client's and investigational sites for all clinical trial related activities.
• Mentor to CRAs.
• Trial Lead CRA role when assigned. Performs additional roles and functions for US ICRO as assigned; such as participating/leading special project initiatives and committees.
• Is an essential contributor for the assessment and development of processes.
Serve as a thought leader and expert on monitoring processes, procedures, and systems to other CRAs. May represent RAD and region at Management Meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs.
Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
Ensure the site Investigator Folder is up to date and mirrors the Client TMF. Responsible for collecting regulatory documents from site and filing in the Client TMF. Prepare and collect study site documents.
Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism.
Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in conjunction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as an expert to other CRAs on electronic systems. Responsible for assisting with the evaluation, design and implementation of new systems.
Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
Enforce and follow GCP and ICH requirements as appropriate.
Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of other CRAs as assigned.
Manage data query resolution process with sites and across trial and track status updates.
Perform Site Closeout activities per SOPs and applicable regulations.
Travel domestically (and possibly internationally) as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required.
Attend and participate in disease indication and project specific training and general CRA training as required.
Perform additional roles and functions for US ICRO as assigned such as trial Lead CRA, CRA mentor, systems superuser, or committee member.
Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvements.
Support the successful implementation of innovative processes and technologies.
Key Performance Indicators
Meeting of study milestones including study start-up and recruitment timelines.
Ensuring the delivery of high quality data (from individual sites and teams when LCRA) according to agreed timelines following international and local regulations and Client's SOP standards.
Highest quality and timeliness of: updating the Client's electronic systems, monitoring reports, and communication efforts.
Deliver customer satisfaction results for internal and external customers.
Mentoring and leading internal and external teams.
Collaborate with US CD&MA and Field Medical to identify, develop and support sites and to achieve trial objectives.
Completion of extra assignments beyond responsibilities and execution of expectations.
Local individual KPIs as determined by Head of US ICRO and US CD&MA Head.
• Understanding of medical and business knowledge relevant to clinical trial execution.
• Minimum of seven years of CRA experience.
• Solid understanding of clinical trial design, trial execution, and operations.
• Trial Lead CRA experience.
• Demonstrated ability to coordinate, organize, communicate, and manage trial site activities, with knowledge of when to escalate issues to management or clinical team.
• Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations.
• Excellent oral and written communication and presentation skills.
• Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
• Computer literacy and proficiency.
• Experience as a CRA mentor.
Bachelor's degree or higher in a scientific or healthcare discipline preferred. A nursing degree or extensive relevant experience may commensurate.
Interested candidates can share their most updated resume at firstname.lastname@example.org or they can reach out to me on #973-967-3412 Ext:3412