Job Description

Description:

must haves:

• Bachelor’s degree in Life Sciences, Nursing Licensure, Pharmacy, or related scientific field (or equivalent experience) is required. Preferably a Master’s degree or higher.

• Three or more years clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.

. Also, we appreciate those with Real World Evidence (RWE) qualifications and experience.

Position Summary:

The Evidence Generation/RWE Project Manager (EPM) is responsible for the management of all aspects of evidence generation activities for assigned project(s). The EPM, in collaboration with the Medical Sci directors, Scientific advisors, Market Access Leads and managers of his therapeutic area, is accountable for achieving successful delivery of evidence generation and real-world evidence (RWE) activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform the following:

• Being a strategic partner, brings its technical, scientific, and operational expertise in the development and the implementation of the Integrated Evidence Generation Plan within the assigned therapy area.

• Proactively manage project level operational aspects of Study Management Team (SMT) including management of study timeline, budget, resources, and vendors.

• Provide efficient updates on trial progress to the evidence generation operation lead with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.

• Lead study startup process, including but not limited to project internal approvals, protocol development, review and approval, vendor (or data custodian) selection, qualification, and a contracting, conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), filing and archiving the study documents and managing budgets.

• Ensure effective project plans are in place and operational for each study and work proactively with the Study Management Team (SMT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

• Ensure potential study risks are escalated to the attention of the evidence generation operation lead when appropriate.

• Leads and coordinates interactions with internal and external partners to ensure that studies comply with regulatory obligations, follow quality standards and that the results are published according to the plan and the defined deadlines.

• Contributes to the development of the publication plan, including post-hoc analysis of the available datasets. If necessary, coordinate the agreement with authors, the contract with the service provider and supervise the execution of the activity.

• Manage the program budget, make updates, and ensure reporting based on cycles defined by finance.

• Acts as the main point of contact for the global development- medical affairs operation department in charge of execution prospective local studies requiring a collection of adverse events.

• Chair SMT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members, and filed in the Trial Master File (TMF) in a timely manner.

• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the study team.

• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator and vendor payments occur in a timely manner.

• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

• Perform and Supervise the updating of company systems relative to research related activities.

• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the evidence generation team regarding TMF filing, maintenance and archival procedures.

• Effectively provide support to investigators and site managers in the conduct of the studies.

• Other duties including implementation and establishment of the EG/RWE operational foundations as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience: The ideal candidate will offer:

• Bachelor’s degree in Life Sciences, Nursing Licensure, Pharmacy, or related scientific field (or equivalent experience) is required. Preferably a Master’s degree or higher.

• Three or more years clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.

• Five or more years of clinical project management experience at a sponsor or CRO company is preferred for EPM

• Therapeutic experience in oncology and/or Immunology (preferred)

• Experience in the design, classification and execution of observational research studies is preferred.

Knowledge, Skills and Abilities:

• Read, write, and speak fluent English, excellent verbal, and written communication skills

• Must have a thorough knowledge of clinical research concepts, practices, and regulatory regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.

• Highly organized and able to manage multiple tasks and prioritize work to deliver on timelines and key deliverables

• Ability to work individually (independently) as well as on a team

• Meticulous, with strong attention to detail, accuracy, and process adherence

• Highly developed interpersonal, influencing and communication skills to build and maintain effective partnerships with all internal and external stakeholders.

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