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Project Manager/Senior Project Manager

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POST DATE 8/25/2016
END DATE 10/18/2016

Chiltern Trenton, NJ

Trenton, NJ
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree






The Senior/ Project Manager manages the project team in the delivery of quality clinical trial management services to achieve the successful overall project completion. The PM will be expected to maintain an in-depth understanding of customer needs within the project group, to focus on achieving the project s goals and to have knowledge in the assigned therapeutic area. According to his/her knowledge and skills the PM may take over any other tasks, duties, roles and job responsibilities at the discretion of the company and relevant managers.

The PM will provide a customer focused leadership role in managing multiple Phase I through Phase IV clinical research trials across all functional areas. The role holder will assure the understanding and integration of all functions, roles and responsibilities within the clinical project team and will effectively coordinate and manage cross functional teams that deliver clinical projects (Clinical Monitoring, Data Management, Biostatistics, Medical writing, Pharmacovigilance, Regulatory).

The PM will monitor adherence to project contract and budget. In addition the PM is expected to assist with proposal generation within a multifunctional matrix setting. The PM is expected to assist in business development activities to achieve successful awards, maintain a high level of customer satisfaction and therefore ensuring repeat business opportunities.

This is a key role that also needs to ensure learning and knowledge transfer during and at the completion of the project.


* Provides leadership and guidance to the project team to ensure successful execution of all work conducted in the clinical project group and to ensure timely, high quality deliverables

* Works collaboratively with the assigned Medical Project Leader to ensure that all relevant scientific and clinical issues are addressed in planning and execution

* Ensures that the needs and perspectives of all functional areas (Clinical Monitoring, Data Management, Biostatistics, Medical writing, Pharmacovigilance, Regulatory) are taken into account and integrated effectively in planning and execution

* Liaises with the Medical Project Leader to obtain appropriate medical input and assistance to resolve any project issues

* Informs senior management of any relevant specific issues or situations that may require their assistance or intervention and works together in implementing processes to streamline the delivery of services to the customers

* Ensures a high-level analysis of project status as it relates to milestones and customer expectations and ensures project management tools are available and used to track, forecast, report and measure project progress

* Reviews work produced by project teams and supports identification of out-of-scope project work and assesses the need for change orders. Assists project teams in problem resolution such as deviation from project plans

* Develops and maintains positive working relationships with the Medical Project Leader and other project team members and collaborates within the organization to ensure the staff contribute productively to the project

* Provides input and training across all operating units as needed and applicable and gives strategic consulting in relation to customer opportunities

* Strategically assesses performance metrics and makes necessary changes to support project or programme targets. Plans for overall resourcing and utilization of project team members

* Functions as primary liaison between the customer and Linical. This role may be delegated to the functional Team Leader if deemed as necessary (i.e. size of the trial, geographic reasons, language barriers etc.)

* Facilitates the resolution of any problems arising from the client relationships by confronting constructively issues such as initial contract negotiations, project staff performance, turnover on the project, outstanding invoice payments, change order negotiations, etc.

* Plans, organizes and manages all aspects of assigned clinical trial projects together with the Lead CRA and project leadership team and business units (vendor selection, investigator selection processes, investigator meetings, study kick-off meetings, development and distribution of study related materials, management of the ongoing study, drug safety reporting and follow-up, management of the data in conjunction with data management personnel, analysis of data in conjunction with biostatistics, reporting of the data in conjunction with medical writing)

* May review any kind of site visit reports and follow-up letters and verify/have oversight of the relevant action plans

* Performs co-monitoring visits, when needed

* Acts as a bridge between operations, business development and other global support groups and ensures the integration of all functions to ensure client satisfaction

* Provides/creates a Project Management Plan

* Implements and updates project specific planning and tracking

* Implements QC procedures and quality metrics to ensure a high quality standard is maintained throughout the project

* Maintains current knowledge of SOP s and regulatory guidance documents which impact the project group

* Evaluates the project-specific training needs and ensures together with the functional line managers and the Director, GCP Training & Compliance Europe that all necessary training is provided to the project staff to ensure high performance and knowledge

* Manages overall project budget and payment status. Reviews and manages variances between actual and forecast spend across the operational project budget

* Approves and signs off on study-related invoices. Oversees the reconciliation of invoices against scope of work and completed activities, and initiates the change order process as appropriate


* Note:Some listed duties may not be performed by all staff under this job description in accordance to extent of experience, education and developed skills


University/college degree in a life science field or equivalent experience/ education with at least 5 years of clinical research experience in a CRO, biopharmaceutical company or relevant clinical environment and a minimum of 2 years of project management or equivalent study coordination or management experience

Experience with complex project/study management and execution is required. A general knowledge of the clinical trial process and CRO industry is mandatory for this function. Minimum of 2 years experience within a CRO required.

Broad global project management knowledge and experience; drive for results; focus on customers and projects; global orientation /interests; proven expertise in management/ financial control fundamentals; negotiation skills and awareness of regulatory requirements and legal and contract issues; comfortable with presenting at internal/client meetings; extensive acumen in problem solving; ability to build, direct and motivate staff; business development involvement a pre-requisite

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.




Full Time


Email Wanda Craddock