Plan and manage study startup including site identification, qualification, selection and initiation activities Lead Clinical Monitoring activities through site activation, maintenance and study closure Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to Monitoring standards (During all stages of the trial) Communication plan Selection, qualificati

Develops scientific understanding of assigned program and protocol requirements Supports protocol design and development strategy for clinical trials Manages protocol development process; including writing support, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document Contributes to the development of Informed Consent Fo

Lead the development and implementation of submission ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.

Support for global pharmacovigilance of assigned products as needed, including the review and analysis of safety data from clinical studies, the post marketing setting, and the scientific literature; assistance with signal assessments; assistance with the preparation and review of aggregate reports, core documents, and labelling updates as required; assistance with the pr

Ability to evaluate the intent of the study concept and make informed recommendations based on scientific review and information available at the time of the request Ability to effectively communicate with key stakeholders through this initial viability/ feasibility concept phase seeking additional information as required to ensure viability output fulfills the teams requ

Development of protocols for clinical studies. Preparation of clinical development plans. Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, and other FDA submissions. Monitor, review, and summarize safety and efficacy data in ongoing studies. Assist with study design for exploratory development. Will lead the cl

Assist Associate Director and senior leadership in the management of the Phase I Clinical Development outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Assist Associate Director with costing trials for internal planning purposes Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs, , Work

Provide quality leadership and direction to Sponsor's R&D stakeholders on GCP related activities/issues and act as GCP expert/consultant for R&D colleagues. Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas. Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as need

Perform Quality control activities process for TMF submissions to Veeva Vault (VV) eTMF in accordance with the documented process Carry out required activities in VV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process Carry out required activities in VV eTMF for all requests for changes to be made to TMF documents in accordance

Drive sales pipeline for Endoscope Repair and full repair catalog. Grow and retain existing accounts by presenting new solutions, products and services. Prepare and or participate in larger customer or IDN visit presentations. Develop target lists of potential accounts in cooperation with the sales reps. Active role working directly with Sales Leaders to execute overall k

The Sr. CRA is responsible for assisting with the execution of high quality clinical studies and will focus on the oversight and monitoring of investigational sites to ensure compliance and assist with study management activities. The Senior CRA will be a key contributor to the company's clinical department and primarily responsible for the site management of assigned cli

Under the direction and as requested by the the sponsor CPMs, the Contracts and Grants Manager may Assists with the development of Investigator/Institution contracts and site budgets Provides investigator grant estimates for RFPs, upon request Supports site budget negotiations and payment terms as needed Provides strategic insights in the development and negotiation of si

Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1 4 clinical development for development compounds Representing the department and providing subject matter expertise on cross functional project teams Developing and maintaining collaborative working relationship with colleagues within and outside the d

Trial Start Up Group Accountable for advancing study start up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation. Laser focus approach to oversight of start up activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful exe

Follow Standard Operating Procedures (SOPs) Maintain long term client relationships resulting in the expansion of client base. Directly implement initiatives to help build awareness of our company capabilities and services. Uncover immediate needs of target market through leads and follow ups, executing internal and external initiatives to drive profitable growth. Utilize