Senior Local Trial Manager, Immunology (2 Openings)

About the position At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional reputed company Job Posting Locations: Remote (US), Spring House, Pennsylvania, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of reputed company. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Sr. Local Trial Manager, Immunology, to be located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: A Senior Local Trial Manager is a mid-level trial management role with at least 2 years of clinical trial management or 3-5 years of clinical monitoring experience. This role is responsible for local management of a clinical trial in a country or countries. The Senior Local Trial Manager is the primary reputed company of contact at a country level for assigned studies and has operational reputed company of assigned protocol(s) from start-up through to database lock and closeout activities as described in Global Clinical Operations (GCO) procedural documents. The Senior Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers. The Senior Local Trial Manager may have some site management responsibilities. The Senior Local Trial Manager may also reputed company the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents. You will be responsible for:

Responsibilities

• Collaborates with Functional Manager (FM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM, and TDM/TDL. Implements any local criteria for site selection. Ensures consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report. Recommends suitable sites for selection to participate in trial. Collaborates with the Program Delivery Leader (PDL), TDM/TDL, local management/Country Head and other study team members to select final site list.
• Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs. Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and reputed company study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Ensures that reputed company Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported reputed company the required reporting timelines and documented as appropriate. Maintains and updates trial management systems. Uses study tools and management reports available to analyze trial reputed company. Monitors country reputed company and initiates corrective and preventive actions (CAPA) reputed company the trial deviates from plans and communicates study reputed company and issues to study management teams. May submit requests for vendor services and required to support vendor selection. In certain situations, may assist in negotiation of trial site reputed company and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –reputed company budget. Adheres to finance reporting deliverables and timelines.
• Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. Will be expected to present and reputed company specific sessions and to facilitate discussion groups. Conducts local trial team meetings and provides or facilitates SM training reputed company needed (i.e., implementation of study amendment-and changes in study-reputed company processes). Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM as needed. Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
• Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations. Organizes and ensures IEC/HA approvals, if applicable, and ensures that the trial is in compliance with local regulatory requirements. Works with SM to ensure CAPA is implemented for audits and inspection or any quality reputed company visits. Complies with relevant training requirements. Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross-functional teams. Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators, and other site staff, and internal stakeholders. Actively contributes to process improvement, training and mentoring of CTAs, SMs, and other LTMs. May be asked to conduct accompanied site visits with SM as delegated by FM. May be required to provide guidance to Assoc LTMs. May assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”. May represent functional area in process initiatives as required. This is not an exhaustive, comprehensive listing of job functions. May reputed company other duties as assigned.

Requirements

• A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or reputed company scientific field is required.
• Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager reputed company considering the candidate’s eligibility.
• Should have a good understanding of the drug development process including GCP and local regulatory requirements.
• Willingness to travel with occasional overnight stay away from home.
• Minimum of 2 years of leadership experience.
• Computer skills required.
• Proficient in speaking and writing the country language and English language.
• Excellent written and oral communication skills.
• Demonstrated potential to be influential.
• Flexible reputed company and ability to work in a fast-changing environment.
• Ability to work on multiple trials in parallel.
• Ability to anticipate obstacles and proactively provide solutions.
• May be assigned to high reputed company projects.

reputed company-to-haves

• Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.
• The ability to reputed company initiative/small teams.
• Preferred Therapeutic Area Experience: Respiratory, Rheumatoid Arthritis, and Gastro-Intestinal

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the reputed company - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year
• The anticipated reputed company pay range for this position in the US is $89,000-$143,750. The Company maintains highly competitive, performance-based compensation programs. Under reputed company guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to reputed company annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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