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Senior Clinical Project Manager

Kelly Services

Gaithersburg, MD
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Job Details

Job Title Senior Clinical Project Manager

Jobid US33MXMP_BH1426159

Location: Gaithersburg, MD, 20898, USA

Description Kelly Services is seeking a **Senior Clinical Project Manager** for one of our top pharmaceutical clients in **Gaithersburg, MD for a 1 year W2 contract.**

**JOB TITLE: Senior Clinical Project Manager**

Note: Candidates should be available to start as soon as possible. Start date could change, to an earlier date, depending on when the right candidate has been identified. Many educational backgrounds could be appropriate for this role. Clinical trial and oncology department experience mandatory

**Position Summary:**

Plans and manages overall clinical operations for assigned clinical trial s /programs including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area TA strategies and goals.

Provides matrix management of functional area representatives to cross-functional clinical trial teams CTTs .

Attends and supports the Clinical Sub-Team CST .

**Major Duties and Responsibilities:**

Attend and support the CST

Provide matrix management of functional area representatives to cross-functional CTTs

Lead/oversee multiple cross-functional CTTs for complex/global studies

Define and manage accountabilities for all CTT members

Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials

Support development of Protocol Concept Sheet PCS and Clinical Study Protocol CSP

Develop outsourcing specifications for vendor requests for proposal and scope of work agreements

Manage selection of study vendors for assigned studies

Manage the vendor s throughout the life of assigned clinical trials

Select investigational sites with input from Clinical Development and vendors

Review and refine Clinical Operations Plans including study monitoring and other plans

Oversee investigative sites adherence to pertinent regulations through review of monitoring reports,QA-GCP audit reports and communications with investigators, study site personnel and CRAs

Lead ongoing review of data to ensure quality and consistency

Plan and conduct investigator meetings and ad boards, etc.

**Senior CPM Job Description**

Develops and manage program budget s and oversees site agreement/budget negotiation process

Develop and manage program timelines

Oversee the submission of trial-related and essential documents to the Trial Master File

Identify and provide solutions to clinical trial issues or risks

Provide input into non project related activities and development of procedures as requested

Participate as appropriate in internal and external audits

May represent clinical operations on the PDT if applicable

**Other duties as assigned**

**Requirements/Qualifications** :

**Education** :

University degree, preferably in a biologic/scientific discipline


Minimum of 10 years progressive experience in clinical operations including 5 years of clinicalproject management or equivalent.

**Special Skills/Abilities:**

Thorough understanding of country level regulations, ICH and GCP guidelines

Thorough understanding of cross-functional clinical processes including data management,biostatistics, medical writing, drug safety, and regulatory affairs

Ability to lead a cross-functional team in a matrix environment

Strong interpersonal and negotiation skills

Strong verbal and written communications and presentation skills

Proven complex problem solving and decision making abilities.

**Why Kelly?**

**For immediate consideration, if you meet the above requirements, please email a current copy of your CV to or click 'apply now'.**
**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.**

_*Available for purchase and administered by a designated third-party vendor_

_Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce._

**Why Kelly** **®** **?**

At Kelly Services ® , we work with the best. Our clients include 95 of the Fortune 100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.

**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 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

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