May have responsibility for a specific client, drug program, indication or drug compound; Act as main point of contact for the
client after study award and throughout the entire study lifecycle (startup, maintenance, closeout).
1. Study Setup and Planning
a. Manage individual clinical trial projects as assigned.
b. Facilitate Seamless Study Set-Up :
i. Review study protocol and bid / budget information once a study is awarded.
ii. Ensure initial meetings are conducted (e.g. document review meetings, Design, and / or Startup
meetings) with sponsor to ensure client Protocol requirements are understood and applied to the design
of the lab study as well as to relay lab processes to the client.
iii. Consult and advise customer on best or most proper course of action as needed.
iv. Develop, relay and implement the Project Management Plan and Risk Management Plan per study as
applicable; Create cost containment measures.
v. Partner with Study Set-Up team to ensure quality of study set-up.
c. Participate in the proposal development process as applicable.
d. Participate in the business development processes as applicable to Project Services responsibilities.
e. Lead in the development of sponsor specific standards and / or program-specific procedures.
f. Ensure key milestones are met and appropriate resources are available.
g. Oversee the writing of protocol-specific laboratory instructional materials (e.g. manuals, flowcharts, etc.) and
participate in the preparation and maintenance of the laboratory specification documents.
2. Study Activity Monitoring and Closeout
a. Monitor Project Management Plan, timelines, and deliverables, including trend analysis of study specific data,
budget and change orders.
b. Manage study scope changes and study budget.
c. Utilize available tools, metrics, and reports as part of global study monitoring and closeout.
d. Manage all service related issues and implement changes to plan as required.
e. Conduct meetings with internal departments as required to meet needs of study and closeout activities.
f. Monitor quality of study and proactively determine and implement solutions for any issues that arise.
g. Report study progress to internal and external clients.
h. Ensure lessons learned are considered, shared and improvements included in processes as applicable.
3. Proactive lines of communication
a. Build and own client relationship for assigned study and serve as a liaison between Sponsor and project teams.
b. Facilitate Communication with the Client.
i. Act as the single point of contact for client, both responding and triaging communications.
ii. Lead and / or participate in key client facing meetings (investigator meetings, study meetings, etc.).
c. Coordinate customer survey follow-up / ongoing health check calls and overall client relationship building.
d. Lead problem solving and resolution efforts in a timely, client-focused manner.
e. Collaborate with other functional groups within the company where necessary to support milestone
achievement and to manage study issues and obstacles.
f. Serve as a point of escalation for program level issues, while ensuring consistency of delivery on a global level.
g. Coordinate and Triage Study-specific issues.
i. Lead in the identification and resolution of service level issues and where issues affect other projects
within and across programs to ensure that any solution is employed universally. Develop proactive
contingency plans to mitigate laboratory risk.
ii. Escalate issues that impact the study plan or budget and relay any issues or trends to clients as
iii. Facilitate regular review meetings to discuss proactive problem resolution of study specific issues,
utilizing the necessary resources from all relevant internal departments.
4. Project Documentation and Deliverables
a. Coordinate meeting agenda, document minutes, track actions, and provide status updates.
b. Oversee the writing of protocol-specific laboratory instructional documents (e.g. manuals, flowcharts) and
participate in the preparation and maintenance of the laboratory specifications document for each assigned
c. Develop start-up plans including but not limited to a program / project monitoring and communication plan,
including tracking of milestones and timelines, risk management and action logs. As required, prepare and present
study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional
training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training
meetings, site refresher meetings, etc.).
5. Participate in Investigator Meetings and Training Activities
a. Represent the company at Investigator / Monitor meetings, internal and external authorities of regulatory bodies,
and other Face to face meetings.
b. Participate in external and internal audits / inspections as required.
c. As needed, administer study training to sites, CRA and sponsors and establish regular lines of communication
with sites to manage on-going project expectations and issues.
d. All associates will be familiar with the safety, environmental rules and procedures applying to their job and take
reasonable care for their own safety and that of other people.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong interpersonal and client management skills.
Working understanding of medical and clinical research terminology.
Working knowledge of Project Management processes, the company laboratory processes, and / or equivalent working
knowledge of central laboratory operations (kits / supplies, logistics, laboratory operations, specimen storage, data
reporting and transfers, site alerts, etc.) preferred.
Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar
Centralized Laboratory systems preferred.
Experience in successfully leading Phase I-IV clinical trials preferred.
Demonstrated ability to work in a fast-paced while possessing strong organizational skills and a demonstrated ability to
Strong written and verbal communication skills including good command of English language. In certain geographies
where communication in local language is desired (e.g. Japan, China), excellent command of local language with
reasonable proficiency in English preferred.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in Life Sciences and / or related field preferred.
1-3 years of experience in clinical trials / hospital-funded research, project management or laboratory environment
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel
Job ID : R1085689