Kelly Services Senior Clinical Project Manager in Lexington, Massachusetts
Senior Clinical Project Manager: Lexington, MA
Kelly Clinical Resources has an exciting opportunity as a Senior Clinical Project Manager to work for one of our top customers in Lexington, MA.
This is a yearlong contract assignment.
As a Senior Clinical Project Manager placed with Kelly Services you will be responsible for the planning, implementation, execution and management of one or more complex clinical research studies.
Manages clinical outsourcing to CROs and other vendors such as IRT, central and specialty labs, etc.
May author, review and approve various study related documents and plans.
Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required.
Leads cross-functional team and is responsible for the financial management of the study(ies).
Represents and leads the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
Authors/contributes to clinical study documents.
Reviews and approves study related plans generated by Clinical CROs and vendors
Provides input as the subject matter expert for the study during regulatory inspections.
Responsible for the clinical review and/or approval of CRFs, completion guidelines and the data review plan
Responsible for oversight of identification and selection of investigator sites.
Responsible for planning and conducting investigator’s meetings.
Provides input and coordinates the delivery of clinical trial supplies in collaboration with Clinical Supply team.
Collaborates with the cross-functional team on selection and management of clinical vendors.
Liaises and coordinates with document specialists regarding study files.
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
Trains and manages CRO and other clinical vendor activities to ensure the quality meets regulatory requirements.
Monitors the status of clinical data collection of assigned clinical studies.
May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required.
Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact.
Responsible for maintaining tracking information in the clinical trial management system, confirming resolution of data quality issues with the CRO.
Reviews correspondence and monitoring reports relating to the study.
Evaluates CRO and vendor performance for future work.
Provides periodic status reports regarding study timelines, budget issues, accruals, etc.
Global Clinical Programs Lead (CPL) as requested.
Develops and monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors, and investigative sites (as applicable).
Requests and critically evaluates proposals and change orders from CROs and vendors.
Leads team through selection process and provides input into contracts, change orders, and/or work orders.
Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
Supports department initiatives and process improvements.
May mentor other Study Managers.
Education and Experience Requirements
Bachelor’s degree is required. Scientific/health care field preferred, but not required.
Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or
Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
Familiarity with financial budgeting and forecasting or reporting
Requires strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
Ability to work successfully within a cross-functional team and a matrix organization.
Excellent written and oral communication skills.
Ability to interact with investigators, vendors, and individuals at all levels of the organization.
Working knowledge of current global regulatory requirements and guidelines governing clinical research.
Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/escalate problems in a timely manner.
Available for up to 25% domestic and/or international travel.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm