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Lead Project Manager, eCOA

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor’s degree in relevant field, 5-10 years in pharmaceutical industry, Experience with project management, Knowledge of drug development process, Expertise in eCOA preferred.

Key responsabilities:

  • Manage and mentor Project Management staff
  • Oversee quality assurance for deliverables
  • Lead planning, monitoring, and closeout phases
  • Monitor study timelines and financial components
  • Develop problem-solving strategies for issues
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Clario Biotech: Biology + Technology XLarge https://clario.com/
5001 - 10000 Employees
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Job description

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

The Lead Project Manager is responsible for staff management and directing and managing services for client projects to assure high quality, on-time, and on-budget services while promoting excellent customer service.

What you'll do:

Manage designated Project Management staff, which includes:

  • Mentoring and defining career paths by developing core competencies.

  • Ensuring proper training is executed and documented.

  • Conducting reviews of system set-ups and documents to ensure high quality of deliverables in accordance with quality standards and SOPs.

  • Coordinating routine status meetings to facilitate communications, monitor workload, and provide forecasting guidance.

  • Collecting and monitoring defined staff metrics.

Independently lead the Planning and Setup, Monitoring, and Closeout phases of program/study management which includes:

  • Gathering customer requirements and relaying to internal teams.

  • Developing study documentation. 

  • Distributing/tracking equipment.

  • Creating/distributing reports.

  • Archiving study data and documentation.

  • Appropriate setting and fulfilling of customer expectations.

  • Monitor study timelines and manage the financial components of each program/study, which includes:

  • Budget reviews.

  • Revenue forecasting.

  • Scope changes.

  • Invoice reconciliation.

  • Identify potential study risks and mitigations, and escalate as appropriate.

  • Manage internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.

  • Develop and apply problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations.

Additional Duties:

  • Provide primary service line support to cross-trained team members from other service lines

  • May serve as point of contact for focus areas within service lines

  • Influence strategic decision making and implement departmental objectives according to schedule

  • Serve as department lead for operational readiness regarding new product initiatives as applicable within Line of Business

  • May guide study teams in being consistent across Therapeutic Area or Program as pertinent to ensure customer is consistent in study set up, optimizing efficiencies and following customer program objectives

  • Ensure compliance with timely training completion/documentation

  • Present study services at Investigator Meetings or site initiation meetings as needed

  • Attend client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed and participate in sales initiatives to generate incremental revenue

  • Assist with developing training plans and training new members of the Project Management team

  • Perform other duties, assignments, or special projects as time and/or circumstances necessitate

What we look for:

Education:

  • Bachelor’s degree and proven Project Management skills or experience within the industry, including expertise in primary service line and/or support of studies in multiple service lines. 

Experience:

  • Demonstrated ability to mentor staff.

  • 5-10 years of experience in pharmaceutical field (or related industry experience), with an emphasis on project management. 

  • Knowledge of the drug development process.

  • Ideally experience within eCOA or similar industry products.

  • Software Development Life Cycle (SDLC) experience.

  • Excellent organizational, interpersonal, time management, and prioritization skills.

  • Excellent verbal and written communication skills, including ability to communicate effectively in English.

  • Working knowledge of Microsoft Office products.

  • Detail oriented and demonstrated responsiveness to inquiries and requests.

  • Valid passport and ability to travel approximately 20%. 

EEO Statement

Clario is an equal opportunity employer.  Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
EnglishEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Social Skills
  • Time Management
  • Organizational Skills
  • Microsoft Office
  • Verbal Communication Skills
  • Mentorship
  • Customer Service
  • Problem Solving
  • Detail Oriented

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