Associate Project Manager

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life To enable our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies.

Alongside clinical research through our PPD clinical research portfolio our work in Trialmed optimizes each step of the patient journey in clinical trials such as securing sites and recruiting patients allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on now and in the future.

Summarized Purpose:

Manages multiple assigned key studies to ensure delivery within agreed schedule and quality

requirements. To effectively execute the prime contract at a local level by implementing the global studystrategy and proactively managing risks for the best possible outcome for the business. Positivelyrepresent the company to external stakeholders providing excellent customer service and expeditedexcellence. Interprets data on complex issues and makes good business decisions with minimal closely with global functional departments and sites to ensure that all deliverables meet or exceedthe customers time quality and cost expectations. Maintains profitability by ensuring clinical activity isconducted within contract scope. Motivate and inspire local teams to keep the studies on track to asuccessful outcome and capitalise on opportunities arising throughout the lifecycle of the study. Typicallyworks independently on projects of high complexity and varying degrees of unique study challenges(accelerated timelines new indication etc.). Will further act as role model and mentor to less experiencedCPM staff and support them in their daily duties. May be assigned as local support on global and/or multi-country studies supporting the global study lead to ensure smooth communication as well as successfuland timely delivery at local level.

Essential Functions and Other Job Information:

• Acts as the lead study reference for assigned projects which are typically of highcomplexity providing global territorial and site-level oversight and leadershipand managing local clinical operational and quality aspects in compliance withcompany quality framework ICH GCP and international standards throughoutthe entire life cycle from initiation to close-out.

• For certain projects manages all start-up activities or works in collaborationwith the global start-up team. Facilitates successful site qualification visits andsite initiation visits as well as timely ethics committee and regulatory submissions(if appropriate). Reviews and follows up on all questions raised by the ethicscommittees. Ensures potential rate limiting factors (e.g. drug supply vendors)
  are identified and managed to ensure maximum and seamless recruitment.

• Continuously measures and assesses study performance by collecting andanalyzing study metrics to determine where the study stands and to predictfuture status and progress with the overall goal to ensure that contractualobligations are met (or organizing contract amendments as necessary)

• Regularlyreviews projects using tracking and management tools provides status updatesto the O&SS Lead identifies risks and implements proactive solutions andrecovery actions identifies problems and escalates appropriately and in a timelymanner.

• Monitors and analyzes recruitment methods against results in collaboration withGEO and pre-identification processing and retention of patients at sites againsttarget to ensure a strong study funnel and to help implement changes to thestrategy during the study and at close with feedback to appropriate departments to ensure future learnings.

• Ensures timely set up organization content quality and archving of the relevantsections of the local Trial Master File if applicable. Maintains files incl. contractlogs amendment logs and other documents.

• Collaborates with the clinical team and other departments as needed to meetdeliverables of the project. Regularly communicates with the team and leadsteam meetings to ensure that timelines resources interactions and quality aremaintained.

• Communicates with study sites regarding issues such as protocol patientparticipation case report form completion and other study-related issues.

• Highlights to management and finance if additional budget is required to deliverstudy on or ahead of target. Provides financial/invoicing support to financeteams to ensure invoices are paid and queries are resolved in a timely manner.

• Acts as the overall study lead for local studies managing such studies fromaward through to close-out including budget and contract aspects and discussionwith the client around additional patient allocation if the study is likely to beoverrecruited.

• Provides support training and mentorship to other CPM staff in their day-to-dayduties as needed and may further take on additional responsibilities such asprocess improvements managing complex programs andproject coordination responsibilities.

Qualifications:
Education and Experience:

Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to8 years).

Knowledge Skills and Abilities:

• Strong leadership skills effective at mentoring and training and capable of motivating andintegrating teams

• Strong planning and organizational skills to enable effective prioritization of workload and workload ofteam members

• Strong interpersonal and problem solving skills to enable working in a multicultural matrixorganization

• Solid understanding of change management principles

• Comprehensive understanding of the practices processes and requirements of clinical research

• Strong judgment decision making escalation and risk management skills

• Effective oral and written communication skills including English language proficiency

• Capable of evaluating own and team members workload against project budget and adjust resourcesaccordingly

• Strong financial acumen and knowledge of budgeting forecasting and fiscal management

• Strong attention to detail

• In-depth understanding of relevant regulations e.g. ICH/GCP FDA guidelines etc.

• Strong computer skills to effectively use automated systems and computerized applications such asOutlook Excel Word etc.

• Capable of independently managing clinical studies

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.