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.

Responsibilities:

  • 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).

10%

  • 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.

40%

  • 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.

40%

  • 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.

5%

  • 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.

5%

  • 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.

Why Kelly?

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*

Apply today!

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