Clinical Trial Project Managers

(2 positions)

(Immuno-oncology focus)
Location:   Montgomery County Maryland

 

 
Position #:                      1437
Therapeutic Area:          Immuno-Oncology               
Recruiting Status:          Retained Search
Office Location:             Montgomery County Maryland*

*These are in-office positions with the possibility of some remote work
 

Note:   Also seeking VP/Director of Clinical Operations:  Link to job description:    VP/Director of Clinical Ops

Note:   Also seeking Clinical Development Scientist:   Link to job description:    Clinical Development Scientist

 

POSITION SUMMARY

As Clinical Trial Project Manager (CTPM), you will independently lead the study team in the development and execution of complex clinical trials. You will be accountable, globally, to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The CTPM consistently demonstrates leadership and influence when working with study teams, management, and business partners. You will work with diverse teams to apply creative solutions to complex and key technical operational or business problems. This will include opportunities to work with vendors, affiliates/regions, global teams, and other business partners). 

 

Responsibilities

 

       Demonstrating and Growing Clinical Trial/Drug Development                               

  • Lead, influence and project manage large, complex studies and/or multiple smaller studies that deliver positive patient and investigator site experiences and quality data.

  • Partner with other organizations to oversee and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).

  • Be accountable for enrollment strategy and

  • Accountability for trial documentation and ensuring inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g. for high risk areas/hot topics) and coaches others CTPMs and study team in these activities.

  • Lead vendor (including CRO) qualification process, selection, and oversight.

  • Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Company standards of operation in the conduct of clinical trials.

  • Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.

  • Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate

  • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.

  • Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed.

  • Creates, manages, measures, and reports timelines for milestone deliverables.

  • Prepares metrics and updates for management.

 

       Problem Solving and Leadership Development

  • Utilize expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-focused approach to conducting daily business.

  • Recognize inter-relatedness of cross-study team activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across study teams and external partners and make decisions on process and issues affecting study implementation and execution.

  • Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver while reducing and/or mitigating risks.

  • Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders.

  • Contribute to the development of others by acting as a coach for peers as well as new CTPMs, study team members and business partners on aspects of CT process and regional specificities while maximizing shared learning.

  • Identify and lead process improvement activities. Acts as an expert resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as the science allows.

  • Utilize and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering customer needs.
     

Basic Qualifications

  •  Bachelor’s Degree (scientific related field is preferred)

  • 3-5 years experience in a clinical trial related setting

  • Candidates must be legally authorized for employment in the United States

  • Experience in oncology/Immuno-Oncology studies is preferred

 

Additional Preferred Qualifications

  • Solid ability to lead and work effectively cross-culturally with colleagues and with business partners to establish and maintain effective relationships.

  • Be recognized as a leader with demonstrated ability to coach others in process expertise.

  • Adopt strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities

  • Ability to influence without authority

  • Effective and influential communication, self-management, and organizational skills

  • Ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity

  • Prior experience with Good Clinical Practice (GCP)/ICH and local/country regulatory requirements

  • Applied knowledge of project management methodology, processes and tools (e.g., MS Project, MS Excel, MS Powerpoint)

  • Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings

  • Have working knowledge of safety reporting

 

NEXT STEP OPTIONS:

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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