Senior Clinical Project Manager/Clinical Project Manager

OpenKrill; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Precision Medicine Group is seeking a Senior/Project Manager to plan, direct, and deliver clinical study activities ensuring quality, scope, cost, and schedule adherence. You will be the main client contact and coordinate cross-functional teams and vendors to meet project milestones.

The role requires 7+ years in clinical research with global trial experience. Domestic and international travel is expected; extensive coordination and leadership are essential to drive bid defenses and study

Qualifications

• Bachelor’s degree or equivalent in science or health-related field.
• Advanced degree preferred.
• Minimum of 7 years of clinical research experience or proven competencies.
• Experience in managing complex and global trials.

Responsibilities

• Serve as primary point-of-contact and escalation point to the client.
• Coordinate and oversee external vendors to timeline and budget.
• Manage study budget and profitability, identifying out-of-scope activities.
• Develop robust project plans with timelines and risk management.
• Ensure quality management for assigned projects and eTMF readiness.

Job description

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Position Summary:The Senior/Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.

Essential functions of the job include but are not limited to:

• - Serve as primary point-of-contact and primary escalation point to the client
• - Coordinate and oversees all functional services including external vendors to the established timeline and budget
• - Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed.
• - Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities
• - Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives.
• - Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• - Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• - Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• - Establish tracking metrics to monitor trial and team progress towards project goals
• - Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• - Leads both internal and client meetings and set expectations for the project team
• - Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• - Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency
• - Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• - Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• - Perform other duties as assigned by management
• - Remain compliant with organisational training, time-reporting and any other administrative duties as required
• - Provides on-going feedback, for functional team members including annual performance reviews

Minimum Required:

• - Bachelor’s degree or equivalent combination of education/experience in science or health-related
• - Advanced degree preferred
• - Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience
• - Experience in managing complex and global trials
• - Ability to travel domestically and internationally including overnight stays

Other Required:

• - Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project,
• - eTMF, EDC and CTMS
• - Proven communication and interpersonal skills to effectively interface with others in a team setting
• - Proven organizational skills, attention to detail, and a customer service demeanour

Competencies:

• - Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to
• - implement such items
• - Proven knowledge of project management techniques and tools
• - Direct work experience in a global, cross-functional project management environment
• - Good understanding of cross-functional management
• - Good understanding of project planning, risk management and change management with an
• - awareness of appropriate escalation
• - Proven experience in strategic planning, risk management and change management
• - High level of integrity and must inspire and demand the highest standards from a professional
• - and ethical perspective
• - Ability to lead and inspire excellence within a study team
• - Ability to create an environment where study team members have a sense of ownership that will
• - lead to increases in productivity and efficiency
• - Results oriented, accountable, motivated and flexible
• - Proven time management, negotiation, critical thinking, decision making, analytical and
• - interpersonal skills
• - Proven presentation, verbal and written communications skills
• - Good understanding of project management software
• - In depth proven experience in pharmaceutical and/or device research required

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

Candidates must be legally authorized to work in the country of employment without employer sponsorship.