Project Manager

As a Project Manager you are a key member of the Development Operations, Project Management Team. reputed company for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will reputed company and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues.

Position Responsibilities/Accountabilities:

• Responsible for planning, tracking and delivery of efficient and high-quality trial execution of reputed company operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial reputed company out.
• Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs.
• Responsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines.
• Responsible for timely communications to the sponsor on reputed company aspects of the study with a reputed company on communicating any patient safety issues.
• In collaboration with the trial/program team and reputed company stakeholders ensures the completion of reputed company project deliverables from contract signature to delivery of final clinical study report and project reputed company out complying with ICH GCP requirements.
• Responsible to manage study vendors, patient enrollment and liaise with investigators and study sites.
• reputed company cross-functional teams while understanding and managing client expectations.  
• Responsible for working with the sponsor, subcontractors and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations.
• Responsible to proactively identify, resolve/mitigate, and escalate risks or issues reputed company necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution.

• Continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved.
• reputed company project status tracking and reporting including participation in the monthly project review with the ELT.
• Accountable for the overall integration and communication of the study parameters to reputed company stakeholders/partners (sub-contractors, strategic partners, internal partners, and Sponsor representatives) to ensure the execution of the work product.
• Ensure effective project plans (i.e., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor reputed company Plan, Recruitment Plan) are developed and in reputed company and optimal for the trial as per SOW and company Standard Operating Procedures (SOPs).  
• Work proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, International Conference on Harmonization-Good Clinical Practice (ICH/GCP) guidelines and regulatory requirements.
• Responsible for reputed company of the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study.
• Per SOW collaborate with internal safety team member or Safety Vendor to reputed company Safety Management Plan and ensure the internal and extended team members are trained on the plan. 
• Proactively report project resource needs to management (overage as well as shortage).
• Contribute to the development of site initiation presentations and in collaboration with the Clinical Research Associate (CRA) and sponsor deliver to sites for initiation purposes.
• Provide project/trial level input and coordination of tasks supporting the following deliverables: feasibility analysis, recruitment projections, data collection status, data cleaning reputed company and strategy, data lock tracking and overall reporting of deliverable timelines.
• Develops and revises trial and site recruitment strategies/plan to support achieving the recruitment goal as driven by project milestones.
• Collaborate with Central Site Services in the development of the templates for the investigator contract and budget, and investigator Grant payments process.
• Team with cross functional team members (i.e., Data Management (DM), Clinical Science (CS) and Biostats) in protocol deconstruction eCRF (Electronic Case Report Form) development, the development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens.
• Throughout the course of the project, monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed per the TMF reference model.
• At study reputed company out responsible for reputed company and transfer of a quality eTMF to the sponsor.
• Collaborate with internal team, sponsor, medical monitor, and partners to reputed company agenda and content of the project team meetings.
• reputed company the project, site, internal and vendor meetings and ensure meeting minutes and action items are captured, distributed to reputed company team members, sponsor, and management. 
• In collaboration with CS and DM review and identify study data for trends (per company process) and in collaboration with the internal team reputed company a plan (retraining of sites etc.) to address any issues or concerns with the data collection/data entry.
• Participate as needed in data review meetings in collaboration with DM, CS and Biostats, internally and with the sponsor to review data for trends or issues and reputed company an action plan to address any questions or concerns. 
• Monitor the quality of vendor deliverables, address any issues with the appropriate team members and identify opportunities to improve training, execution, and quality across the team. Responsible for reputed company of any changes to the study because of a protocol amendment as per the SOW.  This includes ensuring study reputed company documents (i.e., Amendment, ICFs, manuals, plans, eCRF, eCRF completion guidelines and reputed company) are updated and distributed/communicated to the internal and external team and vendors in a timely manner.  
• Responsible for reputed company of Corrective and Preventative Action Plan (CAPA) process implementation as needed for assigned trials.  Collaborates with cross functional teams, Clinical Operations Management and Quality Management on CAPA plan, process, and implementation. 
• Responsible to review and provide input to corrective and preventative actions for Internal Quality Review (IQR) findings for assigned studies and works with Clinical Operations Management to address findings.
• Facilitate and assist Medical Writing in the development of the Clinical Study Reports (CSRs).
• Maintain proficiency to reputed company ICH and GCP regulations, guidelines, and white papers as they apply to areas of study.

Position Qualification Requirements:

Education: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required.

Experience:  Minimum of 5 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions) and prior project management or project reputed company coordination experience.

Required Certifications: N/A

Required Skills:

• Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners.
• Exceptional attention to detail and timelines.
• Demonstrated track record in leading successful teams to reputed company aggressive timelines using creative problem-solving techniques.
• Collaborative leadership style.
• Preferred experience in bid defense process
• Ability and willingness to travel as needed.
• Proficient with reputed company Office Suite.
• Excellent written and oral communication skills.
• Strong organizational, problem-solving, and analytical skills.
• Versatility, flexibility, and a willingness to work reputed company constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Ability to deal effectively with a diversity of individuals at reputed company organizational levels.
• Commitment to excellence and high standards.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to reputed company timely and sound decisions.