Biotechnology Project Manager Jobs in Maine (NOW HIRING)

Description

JOB SUMMARY

The Global Project Manager (GPM) oversees, leads, and coordinates the cross-functional operational aspects of ongoing global and multi-regional clinical projects to ensure that the clients' goals of time, cost, and quality are met from protocol concept to final clinical study report. This role focuses specifically on Central Nervous System. Also serves as the primary operational contact with the client to ensure appropriate communications, innovative solutions, project budget management, and meeting of timelines

The Global Project Manager is responsible for the successful conduct of all client projects, including client satisfaction, operational delivery, and full compliance with ICH-GCP guidelines, regulatory requirements (FDA, EMA), and SOPs. 

Also responsible for driving process improvements within the project management function that supports larger organizational goals.

RESPONSIBILITIES

• Preparation and implementation of a global project plan (including the Integrated Quality Management Plan (IQMP) and Risk Management Plan with mitigation for high placebo response and diagnostic accuracy) to ensure quality, on-budget, on-time completion of projects in adherence with client specifications.
• Ensure that site facilities and staff are adequate to meet the demands of clinical trials conducted at global level.
• Reviews and provides input to clinical trial protocols and partner with the Clinical Manager to prepare and align the clinical monitoring team on protocol-related activities.
• Review, approve and implement strategies, policies, and standard operating procedures.
• Attend, investigator meetings, governance committees and other meetings related to clinical research activities, as necessary
• Develop, support and comply with annual budget, including billability levels, revenue and expense targets..
• CNS Scale Management: Ensure robust quality control and standardization of specific CNS rating scales (e.g., ADAS-Cog, MMSE, PANSS, HAM-D, EDSS) through proactive rater training and monitoring
• Development of proposals in response to RFPs from pharmaceutical and biotech companies participate in the strategic development of bid defense slides and attend bid defenses .
• Serve as primary operational contact with the sponsor regarding overall study conduct, timelines, quality, risks, financial performance and budget.
• Responsible for allocation of resources to the study including outsourcing and the identification of vendors, and managing resource needs across global regions
• Maintain high-level oversight of global feasibility, regulatory submissions, and country/site activation by collaborating closely with the Global Regulatory Feasibility and Start-Up Lead.
• Receive, aggregate, and evaluate start-up metrics and site greenlight status updates from the Start-Up Lead to ensure overall project timelines remain aligned. 
• Provide strategic leadership and oversight to the Clinical Manager to ensure the clinical monitoring team (CRAs) executes monitoring plans effectively and maintains data quality standards.
• Collaborate with the Clinical Manager to review high-level monitoring trends, non-compliance issues, and critical site deviations escalated from the field.
• Development of project documentation per project scope of work such as project management plan, and ensure all study plans are received on time by cross functional leads on time including but not limited to e.g, case report forms, regulatory binder development, drug accountability logs, screening and enrollment logs.
• Responsible for tracking managing and reporting on the budget allocated to the project and reporting on the overall trial budget.
• Oversee site selection, initiation, and start-up activities in collaboration with the Feasibility, Regulatory and Start-up lead and clinical team, as applicable.
• Oversee interim study conduct, including tracking subject recruitment and enrollment, safety issues including SAE tracking, study drug supply, and monitoring report review in collaboration with the clinical study team.
• Identifies areas in which resources or progress are not consistent with the project plan, drives proactive risk management, and formulate corrective action plan.
• Communicate up-to-date information regarding overall study progress and key milestones (utilizing start-up data provided by the Start-Up Lead for milestones like FPI, and tracking internal metrics for LPV, DBL, CSR, and TMF) to all relevant parties..
• Responsible for study close-out, coordination of data query resolution, and database lock to meet study timelines.
• Oversight of storage of documents, as appropriate, in temporary or long-term storage in accordance with standard procedures (ensuring continuous Audit Readiness for internal quality audits and regulatory inspections).
• Other duties as assigned

TRAVELING

Per study requirements (global travel may be required).

Requirements

REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES

• The position of Global Project Manager requires at least a bachelor's degree (Master's preferred in Life Sciences, Pharmacy, Nursing, or related scientific field), plus approximately 5 to 7 years of direct clinical research project management experience managing projects of various complexity within a CRO or Pharmaceutical environment.
• The position requires project management experience and a skill set developing study procedures and processes a proven track record of managing complex, multi-region, global clinical trials (at least 2+ regions simultaneously).
• Strong CNS Therapeutic Expertise: Extensive operational experience leading CNS trials (e.g., Alzheimer's, Parkinson's, Epilepsy, Depression, Schizophrenia, Multiple Sclerosis, or Rare Neurodevelopmental disorders).
• Strong understanding of CNS endpoints, rater variability challenges, and strategies to mitigate the placebo effect in psychiatric/neurological trials.
• Demonstrated knowledge and a clear understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, Data Management, Bio statistical output, drug safety and regulatory issues, and report generation. 
• Must have proficiency with ICH/GCP guidelines, FDA, EMA, local regulations, and CTMS, EDC, eTMF, and project management tools (e.g., MS Project).  
• Excellent verbal and written communication skills, organizational skills, time-management, customer service, and interpersonal skills are required.