Clinical Project Manager

MLM Medical Labs; Memphis (TN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Benefits package including generousvac

401k with company matching

Job summary

MLM Medical Labs in Memphis, TN is seeking a Clinical Project Manager (full time) to oversee sponsor and CRO-led studies, ensure on-time delivery and adherence to the project plan. You will coordinate with internal teams and external customers, monitor milestones, and manage communications.

Ideal candidates have a BS or MS in science, at least two years of project management experience, strong knowledge of Good Clinical Practice and ICH guidelines, outstanding attention to detail, planning and

Qualifications

• BS or MS in science (Biology/Chemistry)
• Strong knowledge of Good Clinical Practice / ICH guidelines and regulatory requirements
• Minimum two (2) years Project Management experience
• Excellent attention to detail, strong planning, and problem-solving skills
• Strong organizational and time management skills
• Ability to embrace new technologies
• Excellent communication, presentation, interpersonal skills, both written and spoken. Comfortable communicating directly with customers

Responsibilities

• Act as the primary point of contact with external customers (sponsor companies or CROs).
• Understand the study protocol and the corresponding scope of work and monitor progress towards project milestones.
• Work closely with internal scientific staff to track project requirements and progress and communicate with the customer on a regular basis.
• Keep track of time and materials spent on project to monitor against the budget and track project profitability. Coordinate and communicate changes in project scope if needed.
• Create test programs in the laboratory information system in collaboration with database manager
• Ensure project required materials are ordered and available for each project.
• Create and maintain lab manuals, sample request forms, sample handling sheets, and other study related documents.
• Approve safety and PD / PK / biomarker results and forward to the client.
• Act as a point of contact with investigator sites to coordinate/monitor shipments of samples.
• Track the timely completion of laboratory tests to communicate timelines / expected deadlines with sponsor, staff, QC, and data management.

Skills

Project management

Communication skills

Time management

Problem-solving

Education

BS or MS in science (Biology/Chemistry)

Tools

Laboratory information system

Job description

MLM Medical Labs is a leading specialty and central laboratory with comprehensive research services and laboratory capabilities in Europe , South Africa and North America. Offering standard and fully customizable analytical and logistics services across a variety of therapeutic areas, we add value at every stage of the drug development process, from nonclinical and preclinical through phase IV clinical trials.

The international team of over 150 highly skilled and experienced employees supports 300+ studies at any given time. With our labs located in Memphis TN, USA, Gauteng, South Africa and Mönchengladbach, Germany we work on intercontinental projects.

The position

We are looking for a Clinical Project Manager (full time) to support our operations in Memphis, TN.

As a part of the Project Management at MLM, the Clinical Project Manager supports customer projects to deliver on-time and according to the project plan. Clinical Project Managers coordinate and communicate internally and externally.

Your responsibilities:

• Act as the primary point of contact with external customers (sponsor companies or CROs).
• Understand the study protocol and the corresponding scope of work and monitor progress towards project milestones.
• Work closely with internal scientific staff to track project requirements and progress and communicate with the customer on a regular basis.
• Keep track of time and materials spent on project to monitor against the budget and track project profitability. Coordinate and communicate changes in project scope if needed.
• Create test programs in the laboratory information system in collaboration with database manager
• Ensure project required materials are ordered and available for each project.
• Create and maintain lab manuals, sample request forms, sample handling sheets, and other study related documents.
• Approve safety and PD / PK / biomarker results and forward to the client.
• Act as a point of contact with investigator sites to coordinate/monitor shipments of samples.
• Track the timely completion of laboratory tests to communicate timelines / expected deadlines with sponsor, staff, QC, and data management.

Requirements:

• BS or MS in science (Biology/Chemistry)
• Strong knowledge of Good Clinical Practice / ICH guidelines and other applicable regulatory requirements.
• Minimum two (2) years Project Management experience.
• Excellent attention to detail, strong planning, and problem-solving skills.
• Strong organizational and time management skills.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken. Comfortable communicating directly with customers.
• Ability to adhere to established timelines and work in a regulated environment.
• Customer service mentality

Nice to Have:

• Contract Research Organization (CRO) and relevant experience
• Experience in life sciences or laboratory services, project tracking and inventory software.
• Experience working with large clinical trials.

• MLM offers a comprehensive benefits package including generous vacation and holidays, medical, dental, vision and life insurance, and a 401k program with company matching. We support creative, energetic people with a passion for delivering excellence while helping bring new medicines to the world.